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The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including HF patients outside of the present indication, but at risk for future HF events or mortality.
The trial includes patients with New York Heart Association (NYHA) Class II, III, or IV HF who have an elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or an elevated Brain Natriuretic Peptide (BNP)) and/or a prior HF hospitalization (HFH).
The GUIDE-HF IDE trial will include approximately 3600 subjects at approximately 140 North American sites and consists of two arms: a Randomized Arm and a Single Arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Arm - Treatment Group | Experimental | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. |
|
| Randomized Arm - Control Group | Experimental | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. |
|
| Single Arm | Experimental | Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMS™ HF System | Device | The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| Measure | Description | Time Frame |
|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality | The composite of:
added together with equal weighting into a total number of events | 12 months post-implantation (395 days after implant date) |
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | The composite of:
added together with equal weighting into a total number of events. | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The composite of:
added together with equal weighting into a total number of events. | 12 Months Post Implantation |
| (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The composite of:
added together with equal weighting into a total number of events. |
| Measure | Description | Time Frame |
|---|---|---|
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits | The composite outcome of:
added together with equal weighting into a total number of events | 12 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| (Randomized Arm) Cardiovascular Mortality | The number of deaths with cardiovascular cause | 12 months post-implantation |
| (Randomized Arm) All-cause Hospitalizations | The number of hospitalizations of any cause |
Inclusion Criteria:
Diagnosis and treatment for heart failure (HF) (regardless of left ventricular ejection fraction (LVEF)) for > 90 days prior to the date of consent:
a. Subjects should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current American Heart Association (AHA)/American College of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United States, with any intolerance documented.
GUIDE-HF Randomized Arm Only: NYHA Class II, III or IV HF symptoms documented within 30 days prior to consent.
GUIDE-HF Single Arm Only: NYHA Class III HF symptoms documented within 30 days prior to consent.
HF hospitalization (HFH) within 12 months prior to consent and/or elevated N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) (or Brain Natriuretic Peptide (BNP)) within 30 days prior to consent defined as:
≥ 18 years of age
Chest circumference of < 65 inches, if BMI is > 35 kg/m2
Written informed consent obtained from subject
Willing and able to upload pulmonary artery (PA) pressure information and comply with the follow-up requirements
Exclusion Criteria:
Intolerance to all neuro-hormonal antagonists (i.e., intolerance to angiotensin converting enzyme-inhibitors (ACE-I), angiotensin receptor blockers (ARB), angiotensin-neprilysin inhibitors (ARNi), hydralazine/isosorbide dinitrate and beta-blockers)
ACC/AHA Stage D refractory HF (including having received or currently receiving pharmacologic circulatory support with inotropes)
Received or are likely to receive an advanced therapy (e.g., mechanical circulatory support or cardiac transplant) in the next 12 months
NYHA Class IV HF patients with:
Glomerular Filtration Rate (eGFR) < 25 mL/min and non-responsive to diuretic therapy, or receiving chronic dialysis
Inability to tolerate or receive dual antiplatelet therapy or anticoagulation therapy for one month post-implantation
Significant congenital heart disease that has not been repaired and would prevent implantation of the CardioMEMS™ PA Sensor
Implanted with mechanical right heart valve(s)
Unrepaired severe valvular disease
Pregnant or planning to become pregnant in the next 12 months
An active, ongoing infection, defined as being febrile, an elevated white blood cell count, on intravenous antibiotics, and/or positive cultures (blood, sputum or urine).
History of current or recurrent (≥ 2 episodes within 5 years prior to consent) pulmonary emboli and/or deep vein thrombosis
Major cardiovascular event (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, open heart surgery, or stroke, etc.) within 90 days prior to consent
Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) for less than 90 days prior to consent
Enrollment into another trial with an active treatment arm
Anticipated life expectancy of < 12 months
Any condition that, in the opinion of the Investigator, would not allow for utilization of the CardioMEMS™ HF System to manage the subject using information gained from hemodynamic measurements to adjust medications, including the presence of unexpectedly severe pulmonary hypertension (e.g., trans-pulmonary gradient >15) at implant right heart catheterization (RHC), a history of non-compliance, or any condition that would preclude CardioMEMS™ PA Sensor implantation
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| Name | Affiliation | Role |
|---|---|---|
| Nessa Johnson, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner-University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Arizona Cardiovascular Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42206402 | Derived | Desai AS, Zile MR, Ducharme A, Mehra MR, Maisel AS, Sears SF, Costanzo MR, Smart FW, Chien CV, Jonsson O, Hall S, Nie H, Lee FS, Lindenfeld J. Changes in Pulmonary Artery Pressure Following Initiation of Guideline-Directed Medical Therapies in Patients With Heart Failure: Insights From GUIDE-HF. Circ Heart Fail. 2026 Jun;19(6):e013877. doi: 10.1161/CIRCHEARTFAILURE.125.013877. Epub 2026 May 28. | |
| 40223608 |
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22 subjects were not randomized in the Randomized Arm and 43 subjects were not assigned to the Single Arm due to unsuccessful implantation attempts.
Randomized Arm enrolled 1022 subjects across 118 sites, of which 1000 are endpoint-contributing (successfully implanted and randomized). Subject enrollment took place between March 2018 and December 2019, with the last follow-up completed in January 2021.
Single Arm enrolled 1401 subjects across 119 sites, of which 1358 are endpoint-contributing (successfully implanted). Subject enrollment took place between March 2018 and April 2022, with the last follow-up completed in May 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Arm - Treatment Group | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2020 | Mar 31, 2025 |
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|
|
| 12 Months Post-Implantation |
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality | The composite outcome of:
added together with equal weighting into a total number of events | 12 months post-implantation (395 days after implant date) |
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | 12 Months Post Implantation |
| (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | 12 Months Post Implantation |
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis) | The composite outcome of:
added together with equal weighting into a total number of events | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis) | The composite outcome of:
added together with equal weighting into a total number of events | 12 Months Post Implantation |
| (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis) | The composite outcome of:
added together with equal weighting into a total number of events | 12 Months Post Implantation |
| (Randomized Arm) HFHs | The number of recurrent HFHs | 12 months post-implantation |
| (Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis] | The number of recurrent HFHs | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| (Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] | The number of recurrent HFHs | 12 Months Post-Implantation |
| (Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] | The number of recurrent HFHs | 12 Months Post Implantation |
| (Randomized Arm) Intravenous Diuretic Visits | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | 12 months post-implantation |
| (Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| (Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | 12 Months Post Implantation |
| (Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | 12 Months Post-Implantation |
| (Randomized Arm) All-cause Mortality | The number of deaths of any cause | 12 months post-implantation |
| (Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| (Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | 12 Months Post-Implantation |
| (Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | 12 Months Post-Implantation |
| (Randomized Arm) KCCQ-12 | Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits. | Baseline, 6, and 12 months post-implantation |
| (Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis) | Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported. | Baseline, 6, and 12 months post-implantation |
| (Randomized Arm) EQ-5D-5L | Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. | Baseline, 6, and 12 months post-implantation |
| (Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis) | Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. | Baseline, 6, and 12 months post-implantation |
| (Randomized Arm) 6MHW Test | Six Minute Hall Walk (6MHW) Test Distance | Baseline, 6, and 12 months post-implantation |
| (Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis) | Six Minute Hall Walk (6MHW) Test Distance | Baseline, 6, and 12 months post-implantation |
| (Randomized Arm) Safety: Freedom From DSRCs | Freedom from device/system related complications (DSRCs) | 12 months post-implantation |
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits | The composite outcome of:
added together with equal weighting into a total number of events | 12 months post-implantation |
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | 12 Months Post Implantation |
| (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | 12 Months Post Implantation |
| (Single Arm) Intravenous Diuretic Visits | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | 12 months post-implantation |
| (Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
| (Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | 12 months post-implantation |
| (Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | 12 Months Post Implantation |
| (Single Arm) HFHs | The number of HFHs | 12 months post-implantation |
| (Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis] | The number of heart failure hospitalizations (HFHs) | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
| (Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] | The number of heart failure hospitalizations (HFHs) | 12 Months Post Implantation |
| (Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] | The number of heart failure hospitalizations (HFHs) | 12 Months Post Implantation |
| (Single Arm) All-cause Mortality | The number of deaths of any cause | 12 months post-implantation |
| (Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
| (Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | 12 Months Post Implantation |
| (Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | 12 Months Post Implantation |
| (Single Arm) Safety: Freedom From DSRCs | Proportion of subjects with freedom from device/system related complications (DSRCs) | 12 months post-implantation |
| (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | 12 months post-implantation vs 12 months pre-implantation |
| (Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | 12 months post-implantation vs 12 months pre-implantation |
| (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | 12 months post-implantation vs 12 months pre-implantation |
| 12 months post-implantation |
| (Randomized Arm) Frequency of Subject PA Pressure Uploads | The frequency of subject uploads of PA pressure | 12 months post-implantation |
| (Randomized Arm) HF Medication Changes | The number of changes in HF medications | 12 months post-implantation |
| (Randomized Arm) PA Pressure Measurements [Mixed Model Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means. | Baseline through 12 months post-implantation |
| (Randomized Arm) PA Pressure Measurements [AUC Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months. | Baseline through 12 months post-implantation |
| (Randomized Arm) BNP | Change in BNP measurements from baseline | 6 months post-implantation |
| (Randomized Arm) BNP | Change in BNP measurements from baseline | 12 months post-implantation |
| (Randomized Arm) NT-proBNP | Change in NT-proBNP measurements from baseline | 6 months post-implantation |
| (Randomized Arm) NT-proBNP | Change in NT-proBNP measurements from baseline | 12 months post-implantation |
| (Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group | 12 months post-implantation vs 12 months pre-implantation |
| (Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | 12 months post-implantation vs 12 months pre-implantation |
| (Single Arm) KCCQ-12 [Mixed Model Analysis] | Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. | 6 months post-implantation |
| (Single Arm) KCCQ-12 [Mixed Model Analysis] | Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. | 12 months post-implantation |
| (Single Arm) EQ-5D-5L [Mixed Model Analysis] | Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life. | 6 months post-implantation |
| (Single Arm) EQ-5D-5L [Mixed Model Analysis] | Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life. | 12 months post-implantation |
| (Single Arm) 6MHW Test [Mixed Model Analysis] | 6MHW Test Distance | 6 months post-implantation |
| (Single Arm) 6MHW Test [Mixed Model Analysis] | 6MHW Test Distance | 12 months post-implantation |
| (Single Arm) Cardiovascular Mortality | The number of deaths of cardiovascular cause | 12 months post-implantation |
| (Single Arm) All-cause Hospitalizations | The number of hospitalizations of any cause | 12 months post-implantation |
| (Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance | The frequency of subject uploads of PA pressure | 12 months post-implantation |
| (Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance | The frequency of subject uploads of PA pressure | 12 months post-implantation |
| (Single Arm) HF Medication Changes | The number of changes in HF medications | 12 months post-implantation |
| (Single Arm) PA Pressure Measurements [Mixed Model Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means. | Baseline through 12 months post-implantation |
| (Single Arm) PA Pressure Measurements [AUC Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period | Baseline through 12 months post-implantation |
| (Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] | Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline. | 6 months post-implantation |
| (Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] | Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline. | 12 months post-implantation |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Phoenix Cardiovascular Research Group | Phoenix | Arizona | 85018 | United States |
| University of Arizona | Tucson | Arizona | 85719 | United States |
| Washington Regional Medical Center | Fayetteville | Arkansas | 72703 | United States |
| Baptist Health Medical Center | Little Rock | Arkansas | 72205 | United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| John Muir Medical Center | Concord | California | 94520 | United States |
| Adventist Health St. Helena | Deer Park | California | 94574 | United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| University of California at San Diego (UCSD) Medical Center | La Jolla | California | 92037 | United States |
| USC University Hospital | Los Angeles | California | 90033 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | United States |
| Sutter Medical Center, Sacramento | Sacramento | California | 95816 | United States |
| Mercy Medical Group - Cardiology | Sacramento | California | 95819 | United States |
| San Diego Cardiac Center | San Diego | California | 92123 | United States |
| California Pacific Medical Center - Van Ness Campus | San Francisco | California | 94109 | United States |
| Ventura Cardiology Consultants | Ventura | California | 93003 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | United States |
| Bethesda Memorial Hospital | Boynton Beach | Florida | 33466 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33020 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32216 | United States |
| Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Advent Health Orlando | Orlando | Florida | 32803 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Piedmont Athens Regional Medical Center | Athens | Georgia | 30606 | United States |
| University Hospital | Augusta | Georgia | 30901 | United States |
| WellStar Kennestone Hospital | Marietta | Georgia | 30060 | United States |
| Northshore University HealthSystem | Evanston | Illinois | 60201 | United States |
| Advocate Health and Hospitals Corporation | Oakbrook Terrace | Illinois | 60181 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46240 | United States |
| Heart Center of Lake County | Merrillville | Indiana | 46410 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Cardiovascular Research Institute of Kansas | Wichita | Kansas | 67226 | United States |
| Our Lady of the Lake Hospital | Baton Rouge | Louisiana | 70808 | United States |
| Cardiovascular Institute of the South | Houma | Louisiana | 70361 | United States |
| Louisiana State University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | 71105 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| University of Michigan | Ann Arbor | Michigan | 48104 | United States |
| McLaren Health Care Corporation | Auburn Hills | Michigan | 48326 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| MidMichigan Medical Center-Midland | Midland | Michigan | 48640 | United States |
| Providence Hospital | Southfield | Michigan | 48075 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| North Kansas City Hospital | North Kansas City | Missouri | 64116 | United States |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
| BryanLGH Heart Institute | Lincoln | Nebraska | 68506 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Renown Regional Medical Center | Reno | Nevada | 89502 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | 08043 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| New York University Hospital | New York | New York | 10016 | United States |
| Mount Sinai Hospital | New York | New York | 10019 | United States |
| New York-Presbyterian/Columbia University | New York | New York | 10032 | United States |
| Hudson Valley Cardiovascular Practice, P.C. | Poughkeepsie | New York | 12601 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27835 | United States |
| NC Heart and Vascular Research | Raleigh | North Carolina | 27607 | United States |
| WakeMed Hospital | Raleigh | North Carolina | 27610 | United States |
| Akron City Hospital | Akron | Ohio | 44309 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| St. Elizabeth Health Center | Youngstown | Ohio | 44501 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Oklahoma Heart Hospital South | Oklahoma City | Oklahoma | 73135 | United States |
| Oklahoma Heart Institute at Utica | Tulsa | Oklahoma | 74133 | United States |
| Providence Heart and Vascular | Portland | Oregon | 97225 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Pinnacle Health System | Harrisburg | Pennsylvania | 17105 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17603 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Allegheny General Hospital - ASRI | Pittsburgh | Pennsylvania | 15212 | United States |
| The Reading Hospital and Medical Center | West Reading | Pennsylvania | 19611 | United States |
| Main Line Health Center/Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Prisma Health-Midlands | Columbia | South Carolina | 29203 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | United States |
| Tennova Healthcare - Turkey Creek Medical Center | Knoxville | Tennessee | 37920 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| St Thomas Hospital | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Acension Texas Cardiovascular | Austin | Texas | 78705 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Baylor University Hospital | Dallas | Texas | 75246 | United States |
| John Peter Smith Hospital | Fort Worth | Texas | 76104 | United States |
| Park Plaza Hospital | Houston | Texas | 77004 | United States |
| CHI St. Luke's Health Baylor College of Medicine Med. Ctr. | Houston | Texas | 77030 | United States |
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Heart - The Cardiovascular Group, P.C. | Falls Church | Virginia | 22042 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Bon Secours Heart & Vascular Institute | Richmond | Virginia | 23226 | United States |
| Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| Providence Everett Medical Center | Everett | Washington | 98206 | United States |
| Swedish Medical Center - Heart & Vascular | Seattle | Washington | 98122 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| Aspirus Wausau Hospital | Wausau | Wisconsin | 54401 | United States |
| Foothills Medical Centre | Calgary | Alberta | T2N2T9 | Canada |
| Vancouver General Hospital (U of BC) | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Derived |
| Zile MR, Abraham WT, Stevenson LW, Costanzo MR, Angermann CE, Mehra MR, Desai AS, Ducharme A, Johnson N, Henderson J, Lindenfeld J. Relationship Between Remote, Ambulatory Pulmonary Artery Pressures, and All-Cause Mortality in Patients With Chronic Heart Failure. Circ Heart Fail. 2025 Jun;18(6):e012754. doi: 10.1161/CIRCHEARTFAILURE.124.012754. Epub 2025 Apr 14. |
| 37286262 | Derived | Desai AS, Maisel A, Mehra MR, Zile MR, Ducharme A, Paul S, Sears SF, Smart F, Bhatt K, Krim S, Henderson J, Johnson N, Adamson PB, Costanzo MR, Lindenfeld J; GUIDE-HF Investigators. Hemodynamic-Guided Heart Failure Management in Patients With Either Prior HF Hospitalization or Elevated Natriuretic Peptides. JACC Heart Fail. 2023 Jun;11(6):691-698. doi: 10.1016/j.jchf.2023.01.007. Epub 2023 Apr 12. |
| 36456066 | Derived | Zile MR, Mehra MR, Ducharme A, Sears SF, Desai AS, Maisel A, Paul S, Smart F, Grafton G, Kumar S, Nossuli TO, Johnson N, Henderson J, Adamson PB, Costanzo MR, Lindenfeld J. Hemodynamically-Guided Management of Heart Failure Across the Ejection Fraction Spectrum: The GUIDE-HF Trial. JACC Heart Fail. 2022 Dec;10(12):931-944. doi: 10.1016/j.jchf.2022.08.012. Epub 2022 Oct 12. |
| 35266003 | Derived | Zile MR, Desai AS, Costanzo MR, Ducharme A, Maisel A, Mehra MR, Paul S, Sears SF, Smart F, Chien C, Guha A, Guichard JL, Hall S, Jonsson O, Johnson N, Sood P, Henderson J, Adamson PB, Lindenfeld J. The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure: impact of the COVID-19 pandemic. Eur Heart J. 2022 Jul 14;43(27):2603-2618. doi: 10.1093/eurheartj/ehac114. |
| 34461042 | Derived | Lindenfeld J, Zile MR, Desai AS, Bhatt K, Ducharme A, Horstmanshof D, Krim SR, Maisel A, Mehra MR, Paul S, Sears SF, Sauer AJ, Smart F, Zughaib M, Castaneda P, Kelly J, Johnson N, Sood P, Ginn G, Henderson J, Adamson PB, Costanzo MR. Haemodynamic-guided management of heart failure (GUIDE-HF): a randomised controlled trial. Lancet. 2021 Sep 11;398(10304):991-1001. doi: 10.1016/S0140-6736(21)01754-2. Epub 2021 Aug 27. |
| FG001 | Randomized Arm - Control Group | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| FG002 | Single Arm | Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| Complete 6 Month Follow-Up |
|
| COMPLETED | Completed 12 Month Follow-Up |
|
| NOT COMPLETED |
|
|
The endpoint-contributing population consists of patients who were successfully implanted.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Arm - Treatment Group | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| BG001 | Randomized Arm - Control Group | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| BG002 | Single Arm | Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
| ||||||||||
| New York Heart Association (NYHA) Class | The New York Heart Association (NYHA) functional classification of HF symptoms is designed to subjectively quantify an individual's burden of congestive symptoms in order to provide specific medical and device interventions appropriate for the patient's condition. NYHA classifications are categorized as class I (no limitation of physical activity), class II (slight limitation of physical activity), class III (marked limitation of physical activity) to class IV (symptoms of heart failure at rest). The higher the class, the more severe the heart failure symptoms. | Data not available in 1 subject in Single Arm. Subject did not record NYHA class following reconsent. | Count of Participants | Participants |
| |||||||||
| Medical History - Ischemic etiology | Count of Participants | Participants |
| |||||||||||
| Medical History - Previous myocardial infarction | Count of Participants | Participants |
| |||||||||||
| Medical History - Previous percutaneous coronary intervention | Count of Participants | Participants |
| |||||||||||
| Medical History - Previous coronary artery bypass grafting | Count of Participants | Participants |
| |||||||||||
| Medical History - Diabetes | Count of Participants | Participants |
| |||||||||||
| Medical History - Cerebrovascular accident | Count of Participants | Participants |
| |||||||||||
| Medical History - Atrial flutter or fibrillation | Count of Participants | Participants |
| |||||||||||
| Treatment History - Previous cardiac resynchronization therapy | Count of Participants | Participants |
| |||||||||||
| Treatment History - Previous implantation of defibrillator | Count of Participants | Participants |
| |||||||||||
| Heart rate | Mean | Standard Deviation | beats per minute (bpm) |
| ||||||||||
| Systolic blood pressure | Data not available for 1 subject from Single Arm. | Mean | Standard Deviation | mmHg |
| |||||||||
| Diastolic blood pressure | Data not available for 1 subject from Single Arm. | Mean | Standard Deviation | mmHg |
| |||||||||
| Left ventricular ejection fraction | Mean | Standard Deviation | % |
| ||||||||||
| Left ventricular ejection fraction > 40% | Count of Participants | Participants |
| |||||||||||
| Pulmonary artery (PA) systolic pressure | Mean | Standard Deviation | mmHg |
| ||||||||||
| PA Diastolic Pressure | Mean | Standard Deviation | mmHg |
| ||||||||||
| PA Mean Pressure | Mean | Standard Deviation | mmHg |
| ||||||||||
| Pulmonary capillary wedge pressure | Data not available in 2 subjects from Randomized Arm (Treatment Group) and 8 subjects from Single Arm. | Mean | Standard Deviation | mmHg |
| |||||||||
| Cardiac output | Mean | Standard Deviation | L/min |
| ||||||||||
| Cardiac index | Mean | Standard Deviation | L/min/m2 |
| ||||||||||
| Ambulatory Hemodynamics during First Week | Ambulatory hemodynamics during the first week are pulmonary artery pressure readings collected from the CardioMEMS sensor during the initial week following its implantation. These readings serve as baseline measurements rather than study outcomes, as hemodynamic data can only be gathered using the CardioMEMS sensor post-implantation. | Data not available for 4 subjects in Randomized Arm (Control Group) and 8 subjects in Single Arm. | Mean | Standard Deviation | mmHg |
| ||||||||
| Ambulatory Heart Rate during First Week | Ambulatory heart rate during the first week are heart rate readings collected from the CardioMEMS sensor during the initial week following its implantation. These readings serve as baseline measurements rather than study outcomes, as these measurements can only be gathered using the CardioMEMS sensor post-implantation. | Data not available in 4 subjects from Randomized Arm (Control Group) and 8 subjects in Single Arm. | Mean | Standard Deviation | beats per minute (bpm) |
| ||||||||
| Laboratory Analyses - Serum creatinine level | Data not available in 2 subjects from Randomized Arm (Treatment Group), 8 subjects from Randomized (Control Group) and 5 subjects from Single Arm. | Mean | Standard Deviation | μmol/L |
| |||||||||
| Laboratory Analyses - Estimated glomerular filtration rate | Data not available for 2 subjects from Randomized Arm (Treatment Group), 9 subjects from Randomized Arm (Control Group) and 5 subjects from Single Arm. | Mean | Standard Deviation | ml/min/1.73m2 |
| |||||||||
| Laboratory Analyses - Brain Natriuretic Peptide (BNP) | Data not available for 236 subjects from Randomized Arm (Treatment Group), 247 subjects from Randomized Arm (Control Group) and 688 subjects from Single Arm. | Mean | Standard Deviation | pg/mL |
| |||||||||
| Laboratory Analyses - N-terminal pro-B-type natriuretic peptide (NT-proBNP) | Data not available for 278 subjects from Randomized Arm (Treatment Group), 278 subjects from Randomized Arm (Control Group) and 715 subjects from Single Arm. | Mean | Standard Deviation | pg/mL |
| |||||||||
| ACE-Inhibitor or ARB or ARNi | Count of Participants | Participants |
| |||||||||||
| ARNi | Count of Participants | Participants |
| |||||||||||
| Beta Blocker | Count of Participants | Participants |
| |||||||||||
| Mineralocorticoid Receptor Antagonist | Count of Participants | Participants |
| |||||||||||
| Diuretic | Count of Participants | Participants |
| |||||||||||
| Hydralazine | Count of Participants | Participants |
| |||||||||||
| Nitrate | Count of Participants | Participants |
| |||||||||||
| SGLT2 Inhibitor | Data not available for 345 subjects from Randomized Arm (Treatment Group), 363 subjects from Randomized Arm (Control Group) and 363 subjects from Single Arm. | Count of Participants | Participants |
| ||||||||||
| Enrollment Type - Prior Heart Failure Hospitalization Only | One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. | Count of Participants | Participants |
| ||||||||||
| Enrollment Type - Prior Elevated NT-proBNP/BNP | One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. | Count of Participants | Participants |
| ||||||||||
| Enrollment Type - Prior Heart Failure Hospitalization and Elevated NT-proBNP/BNP | One subject from Randomized Arm (Control Group) was enrolled and randomized but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. Fourteen (14) subjects from the Single Arm were enrolled and implanted successfully but did not meet entry criteria for either a prior HFH or elevated NT-proBNP or BNP. | Count of Participants | Participants |
| ||||||||||
| KCCQ-12 Score | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. | Data not available for 3 subjects from Randomized Arm (Treatment Group), 6 subjects from Randomized Arm (Control Group) and 7 subjects from Single Arm. | Mean | Standard Deviation | scores on a scale |
| ||||||||
| 6-minute Walk Test (6MHW) | Data not available for 23 subjects from Randomized Arm (Treatment Group), 21 subjects from Randomized Arm (Control Group) and 101 subjects from Single Arm. | Mean | Standard Deviation | meters |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality | The composite of:
added together with equal weighting into a total number of events | The primary endpoint was analyzed in the endpoint-contributing population, which included subjects that were successfully implanted and randomized. | Posted | Number | events per patient-year | 12 months post-implantation (395 days after implant date) |
|
|
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| Primary | (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | The composite of:
added together with equal weighting into a total number of events. | The primary endpoint limited to the follow-up period occurring "Pre-COVID-19" or "During COVID-19" was analyzed in the endpoint-contributing population including subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate in the Andersen-Gill model. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The composite of:
added together with equal weighting into a total number of events. | The primary endpoint was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | (Randomized Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The composite of:
added together with equal weighting into a total number of events. | The primary endpoint was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post-Implantation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality | The composite outcome of:
added together with equal weighting into a total number of events | The primary endpoint was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. | Posted | Number | events per patient-year | 12 months post-implantation (395 days after implant date) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | The primary endpoint limited to the follow-up period occurring "Prior to COVID-19" or "During COVID-19" was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | The primary endpoint was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | (Single Arm) Composite Outcome of (1) HFHs, (2) Intravenous Diuretic Visits, and (3) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | The primary endpoint was compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group, but excluding primary endpoint events adjudicated as either related or possibly related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits | The composite outcome of:
added together with equal weighting into a total number of events | The secondary outcome (composite of HFH and ED/OP visits) was analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. | Posted | Number | events per patient-year | 12 months post-implantation |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis) | The composite outcome of:
added together with equal weighting into a total number of events | The secondary outcome (composite of HFH and ED/OP visits) limited to the follow-up period occurring prior to COVID-19 or during COVID-19 were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis) | The composite outcome of:
added together with equal weighting into a total number of events | The secondary outcome (composite of HFH and ED/OP visits) was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Randomized Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis) | The composite outcome of:
added together with equal weighting into a total number of events | The composite outcome was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Randomized Arm) HFHs | The number of recurrent HFHs | The number of recurrent HFHs were analyzed within the full cohort of endpoint-contributing population, which includes subjects of NYHA class II/III/IV that were successfully implanted and randomized. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Randomized Arm) HFHs [Follow-up Based COVID-19 Sensitivity Analysis] | The number of recurrent HFHs | The number of recurrent HFHs limited to the follow-up period occurring prior to COVID-19 or during COVID-19 were analyzed within the full cohort of endpoint-contributing population, which includes subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
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| Secondary | (Randomized Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] | The number of recurrent HFHs | The number of recurrent HFHs was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post-Implantation |
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| Secondary | (Randomized Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] | The number of recurrent HFHs | The number of recurrent HFHs was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Randomized Arm) Intravenous Diuretic Visits | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | The number of ED/OP visits were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Randomized Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | The number of ED/OP visits limited to the follow-up period occurring prior to and during COVID-19 were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
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| Secondary | (Randomized Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | The outcome was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Randomized Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation visits for intravenous diuretic therapy | The outcome was analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post-Implantation |
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| Secondary | (Randomized Arm) All-cause Mortality | The number of deaths of any cause | The number of death events of any cause were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Randomized Arm) All-cause Mortality [Follow-up Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The number of death events of any cause limited to the follow-up period occurring prior to and during COVID-19 were analyzed in the full cohort of endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized. All subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | The COVID-19 pandemic occurred during follow-up after enrollment of all subjects. Events were analyzed through March 13, 2020 for pre-COVID-19 (median follow-up: 8.4 months) and after March 13, 2020 for during COVID-19 (median follow-up: 5.2 months). |
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| Secondary | (Randomized Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The mortality events were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post-Implantation |
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| Secondary | (Randomized Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The mortality events were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. All subjects were enrolled before COVID-19 period (March 13, 2020). The event based COVID-19 sensitivity analysis compares treatment effect by excluding events adjudicated as either related or possible related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post-Implantation |
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| Secondary | (Randomized Arm) KCCQ-12 | Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Change from baseline KCCQ-12 scores were evaluated at 6 and 12-month visits. | Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. The Least Square Means (LSM) difference in KCCQ-12 Overall Summary Score at 6 months, and 12 months visits from baseline during overall follow-up in Treatment and Control groups were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, 6, and 12 months post-implantation |
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| Secondary | (Randomized Arm) KCCQ-12 (Subject Based COVID-19 Sensitivity Analysis) | Health status as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life over a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. Descriptive statistics of KCCQ-12 scores at baseline, 6 and 12-month visits were reported. | The KCCQ-12 score at baseline, 6 months, and 12 months were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6, and 12 months post-implantation |
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| Secondary | (Randomized Arm) EQ-5D-5L | Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. | Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. The Least Square Means (LSM) difference in EQ-5D-5L VAS at 6 months and 12 months visits from baseline during overall follow-up for Treatment and Control groups were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, 6, and 12 months post-implantation |
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| Secondary | (Randomized Arm) EQ-5D-5L (Subject Based COVID-19 Sensitivity Analysis) | Health status as assessed by the EuroQol 5-Dimension, 5-Level (EQ-5D-5L) Questionnaire The EQ-5D-5L Questionnaire is a standardized measure of health status that consists of a descriptive system and a visual analog score (VAS). The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score represents a better quality of life. | The EQ-5D-5L score at baseline, 6 months, and 12 months were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 6, and 12 months post-implantation |
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| Secondary | (Randomized Arm) 6MHW Test | Six Minute Hall Walk (6MHW) Test Distance | Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. Subjects who were unable to walk due to heart failure symptoms were assigned zero meters. The Least Square Means (LSM) difference in 6MHW distance at 6 months and 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | meters, m | Baseline, 6, and 12 months post-implantation |
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| Secondary | (Randomized Arm) 6MHW Test (Subject Based COVID-19 Sensitivity Analysis) | Six Minute Hall Walk (6MHW) Test Distance | The 6MHW distance at baseline, 6 months, and 12 months were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV that were successfully implanted and randomized into Treatment or Control groups. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Mean | Standard Deviation | meters, m | Baseline, 6, and 12 months post-implantation |
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| Secondary | (Randomized Arm) Safety: Freedom From DSRCs | Freedom from device/system related complications (DSRCs) | The overall freedom from DSRCs across the endpoint-contributing population were analyzed. The analysis population included all subjects in the efficacy population of the Randomized Arm (i.e. Randomized to Treatment and Control group). | Posted | Count of Participants | Participants | 12 months post-implantation |
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| Secondary | (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits | The composite outcome of:
added together with equal weighting into a total number of events | The secondary endpoint was compared between subjects qualifying with elevated NT-proBNP/BNP levels only and subjects qualifying with a prior HF hospitalization only. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | The secondary outcome events limited to the follow-up period were compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
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| Secondary | (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | The results were compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) Composite Outcome of (1) HFHs and (2) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | The composite outcome of:
added together with equal weighting into a total number of events | The results were compared between subjects in the qualifying with elevated NT-proBNP/BNP levels only group and subjects in the qualifying with prior HF hospitalization only group, but excluding primary endpoint events adjudicated as either related or possibly related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) Intravenous Diuretic Visits | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | The secondary endpoint was analyzed in the endpoint-contributing populations, which consists of subjects with successful implantation in three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Annualized event rate was estimated from the Andersen-Gill model. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Single Arm) Intravenous Diuretic Visits [Follow-up Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | The endpoints limited to the follow-up period was analyzed in the endpoint-contributing populations, which consists of subjects with successful implantation in three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
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| Secondary | (Single Arm) Intravenous Diuretic Visits [Subject Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | The event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Single Arm) Intravenous Diuretic Visits [Event Based COVID-19 Sensitivity Analysis] | The number of emergency department/hospital outpatient observation (ED/OP) visits for intravenous diuretic therapy | The event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization, but excluding events adjudicated as either related or possibly related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) HFHs | The number of HFHs | The secondary endpoint was analyzed in the endpoint-contributing populations, which consists of subjects with successful implantation in three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Annualized event rate was estimated from the Andersen-Gill model. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Single Arm) HFHs [Follow-Up Based COVID-19 Sensitivity Analysis] | The number of heart failure hospitalizations (HFHs) | The secondary outcome events limited to the follow-up period occurring prior to COVID-19 or during COVID-19 was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
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| Secondary | (Single Arm) HFHs [Subject Based COVID-19 Sensitivity Analysis] | The number of heart failure hospitalizations (HFHs) | The HFH event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) HFHs [Event Based COVID-19 Sensitivity Analysis] | The number of heart failure hospitalizations (HFHs) | The HFH event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization, but excluding events adjudicated as either related or possibly related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) All-cause Mortality | The number of deaths of any cause | The secondary endpoint was analyzed in the endpoint-contributing populations, which consists of subjects with successful implantation in three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Annualized event rate was estimated from the Andersen-Gill model. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Secondary | (Single Arm) All-cause Mortality [Follow-Up Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The event limited to the follow-up period occurring prior to COVID-19 or during COVID-19 was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. Subjects were assessed based on their follow-up time occurring pre- or during-COVID periods using a time-varying covariate. The Arm/Group Titles represent the follow-up time period. | Posted | Number | events per patient-year | Events were analyzed through March 13, 2020 for pre-COVID-19 analysis (median follow-up: 5.4 months) and from March 13, 2020 through the end of subject's follow-up for during COVID-19 analysis (median follow-up: 11.2 months). |
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| Secondary | (Single Arm) All-cause Mortality [Subject Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The HFH event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization. The "Pre-COVID-19" Arms/Groups assess participants that completed study participation prior to the start of the COVID-19 pandemic, and the "During COVID-19" Arms/Groups assess participants that completed study participation during the COVID-19 pandemic. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) All-cause Mortality [Event Based COVID-19 Sensitivity Analysis] | The number of deaths of any cause | The event was compared between subjects in the three qualifying groups: elevated NT-proBNP/BNP only, previous HF hospitalization only or both elevated NT-proBNP/BNP and previous HF hospitalization, but excluding events adjudicated as either related or possibly related to COVID-19. | Posted | Number | events per patient-year | 12 Months Post Implantation |
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| Secondary | (Single Arm) Safety: Freedom From DSRCs | Proportion of subjects with freedom from device/system related complications (DSRCs) | Posted | Count of Participants | Participants | 12 months post-implantation |
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| Secondary | (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP Only Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | All subjects met qualification criteria of prior elevated NT-proBNP/BNP only and had successful implantation of CardioMEMS™ HF System. | Posted | Number | events per patient-year | 12 months post-implantation vs 12 months pre-implantation |
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| Secondary | (Single Arm) HFHs Post- vs. Pre-implantation [Previous HF Hospitalization Only Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | All subjects met qualification criteria of previous HF hospitalization only and had successful implantation of CardioMEMS™ HF System. | Posted | Number | events per patient-year | 12 months post-implantation vs 12 months pre-implantation |
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| Secondary | (Single Arm) HFHs Post- vs. Pre-implantation [Elevated NT-proBNP/BNP and Previous HF Hospitalization Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | All subjects met qualification criteria of elevated NT-proBNP/BNP and previous HF hospitalization and had successful implantation of CardioMEMS™ HF System. | Posted | Number | events per patient-year | 12 months post-implantation vs 12 months pre-implantation |
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| Other Pre-specified | (Randomized Arm) Cardiovascular Mortality | The number of deaths with cardiovascular cause | The number of deaths that were cardiovascular in nature were analyzed in the endpoint contributing population, which includes subjects of NYHA class II/III/IV with successful implantation and randomized. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) All-cause Hospitalizations | The number of hospitalizations of any cause | The number of all-cause hospitalizations were analyzed in the endpoint-contributing population, which included subjects of NYHA class II/III/IV with successful implantation and randomized. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) Frequency of Subject PA Pressure Uploads | The frequency of subject uploads of PA pressure | Subjects with at least one eligible day during the analysis period are included in the analysis. The daily compliance (percentage of eligible days in which a subject had a reading) and weekly compliance (percentage of weeks in which a subject had at least one reading) per subject were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. Days when subjects did not have any reading taken during the eligible days are counted as zeroes. | Posted | Mean | Standard Error | Percentage | 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) HF Medication Changes | The number of changes in HF medications | Within the endpoint-contributing population, which included subjects of NYHA class II/II/IV with successful implantation and randomized into Treatment and Control group, the number of subjects with medication changes and the number of medications changes were recorded by different classes of HF medications. | Posted | Number | Number of medication changes | 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) PA Pressure Measurements [Mixed Model Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means. | Subjects that have a baseline value and at least one value at either 6- or 12-month visits were analyzed. The Least Square Means (LSM) difference in PA pressure measurements at 6 months and 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline through 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) PA Pressure Measurements [AUC Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using an area under the curve (AUC) analysis of change from baseline on all PA pressure readings through 12 months. | The PA pressure measurements were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. | Posted | Mean | Standard Deviation | mmHg*Days | Baseline through 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) BNP | Change in BNP measurements from baseline | Subjects that have a baseline value and at least one value at 6-month visit were analyzed. The Least Square Means (LSM) difference in BNP levels at 6 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | 6 months post-implantation |
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| Other Pre-specified | (Randomized Arm) BNP | Change in BNP measurements from baseline | Subjects that have a baseline value and at least one value at 12-month visits were analyzed. The Least Square Means (LSM) difference in BNP levels at 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) NT-proBNP | Change in NT-proBNP measurements from baseline | Subjects that have a baseline value and at least one value at 6-month visit were analyzed. The Least Square Means (LSM) difference in NT-proBNP levels at 6 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | 6 months post-implantation |
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| Other Pre-specified | (Randomized Arm) NT-proBNP | Change in NT-proBNP measurements from baseline | Subjects that have a baseline value and at least one value at 12-month visit were analyzed. The Least Square Means (LSM) difference in NT-proBNP levels at 12 months from baseline in both Treatment and Control groups during the overall follow-up period were analyzed using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | 12 months post-implantation |
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| Other Pre-specified | (Randomized Arm) HFHs Post- vs. Pre-implantation [Treatment Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation in the Treatment group | A comparison of HF hospitalizations in the 12 months prior to implantation compared to 12 months post implantation for the endpoint contributing population, which includes subjects of NYHA class II/III/IV with successful implantation and randomized into the Treatment group were analyzed. | Posted | Number | events per patient-year | 12 months post-implantation vs 12 months pre-implantation |
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| Other Pre-specified | (Randomized Arm) HFHs Post- vs. Pre-implantation [Control Group] | The number of HFHs at 12 months post-implantation compared to the number of HFHs in the 12 months prior to implantation | A comparison of HF hospitalizations in the 12 months prior to implantation compared to 12 months post implantation for the endpoint contributing population, which includes subjects of NYHA class II/III/IV with successful implantation and randomized into the Control group were analyzed. | Posted | Number | events per patient-year | 12 months post-implantation vs 12 months pre-implantation |
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| Other Pre-specified | (Single Arm) KCCQ-12 [Mixed Model Analysis] | Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. | The change in KCCQ-12 scores at 6 months visit from baseline in each qualification criteria group were analyzed using mixed model analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | 6 months post-implantation |
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| Other Pre-specified | (Single Arm) KCCQ-12 [Mixed Model Analysis] | Health status as assessed by the KCCQ-12 The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated health-related quality of life measure for heart failure and was qualified by the FDA as a medical device development tool in 2017. The KCCQ-12 quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and quality of life on a scale from 0 to 100. An overall summary score (OSS) is derived by averaging scores from each domain, with a higher score reflecting a better health status. | The change in KCCQ-12 scores at 12 months visit from baseline in each qualification criteria group were analyzed using mixed model analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) EQ-5D-5L [Mixed Model Analysis] | Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life. | The EQ-5D-5L scores at 6-month visit from baseline for each qualification criteria group were compared using Mixed Model Analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | 6 months post-implantation |
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| Other Pre-specified | (Single Arm) EQ-5D-5L [Mixed Model Analysis] | Health status as assessed by the EQ-5D-5L Questionnaire. The data represents the EQ Visual Analogue Scale (VAS) subscale. The VAS records the subject's self-rated health status which ranges from a score of 0 (worst health you can imagine) to 100 (best health you can imagine). A higher VAS score for represents a better quality of life. | The EQ-5D-5L scores at 12-month visit from baseline for each qualification criteria group were compared using Mixed Model Analysis. | Posted | Least Squares Mean | Standard Error | scores on a scale | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) 6MHW Test [Mixed Model Analysis] | 6MHW Test Distance | The 6MHW distance at 6 months from baseline in each qualification criteria group were compared using mixed model analysis. Subjects who were unable to walk due to heart failure symptoms were assigned zero meters. | Posted | Least Squares Mean | Standard Error | meters, m | 6 months post-implantation |
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| Other Pre-specified | (Single Arm) 6MHW Test [Mixed Model Analysis] | 6MHW Test Distance | The 6MHW distance at 12 months from baseline in each qualification criteria group were compared using mixed model analysis. Subjects who were unable to walk due to heart failure symptoms were assigned zero meters. | Posted | Least Squares Mean | Standard Error | meters, m | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) Cardiovascular Mortality | The number of deaths of cardiovascular cause | The number of deaths that were cardiovascular in nature were analyzed in all three qualification criteria groups. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) All-cause Hospitalizations | The number of hospitalizations of any cause | All-cause hospitalizations (overnight hospitalizations for any reason, including HF) were analyzed in all three qualification criteria groups. | Posted | Number | events per patient-year | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) Frequency of Subject PA Pressure Uploads - Daily Compliance | The frequency of subject uploads of PA pressure | Subjects with at least one eligible day during the analysis period are included in the analysis. The daily compliance (percentage of eligible days in which a subject had a reading) per subject were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. Days when subjects did not have any reading taken during the eligible days are counted as zeroes. | Posted | Mean | Standard Deviation | Percentage | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) Frequency of Subject PA Pressure Uploads - Weekly Compliance | The frequency of subject uploads of PA pressure | Subjects with at least one eligible day during the analysis period are included in the analysis. The weekly compliance (percentage of weeks in which a subject had at least one reading) per subject were analyzed in the endpoint contributing population that had at least one reading post-discharge from the implantation. A week is considered eligible if the subject was eligible for readings three or more days during that week. | Posted | Mean | Standard Deviation | Percentage | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) HF Medication Changes | The number of changes in HF medications | The number of subjects with medication changes and the total number of medications changes are provided below for different classes of HF medications for each qualification criteria group. | Posted | Number | Number of events | 12 months post-implantation |
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| Other Pre-specified | (Single Arm) PA Pressure Measurements [Mixed Model Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using a mixed linear model at fixed time points (Baseline, 6 months, and 12 months) producing least-squares means. | Change in PA pressure at 6 and 12 month visits from baseline was analyzed in each qualification group using a mixed model analysis. | Posted | Least Squares Mean | Standard Error | mmHg | Baseline through 12 months post-implantation |
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| Other Pre-specified | (Single Arm) PA Pressure Measurements [AUC Analysis] | Changes in PA pressure relative to baseline for systolic, diastolic, and mean PA pressures analyzed using area under the curve (AUC) analysis of PA pressure across the full follow-up period | Change in PA pressure at 6 and 12 month visits from baseline were analyzed in each qualification group using AUC analysis. | Posted | Mean | Standard Deviation | mmHg*Days | Baseline through 12 months post-implantation |
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| Other Pre-specified | (Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] | Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months visits from baseline. | Either BNP or NT-proBNP levels were measured at baseline, 6 months and 12 months in each qualification criteria group. Change from baseline at 6 months were analyzed using mixed model analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | 6 months post-implantation |
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| Other Pre-specified | (Single Arm) NT-proBNP (or BNP) [Mixed Model Analysis] | Either change in N-terminal pro-brain natriuretic peptide (NT-proBNP) or Brain natriuretic peptide (BNP) measurements at 6 months and 12 months visits from baseline. | Either BNP or NT-proBNP levels were measured at baseline, 6 months and 12 months in each qualification criteria group. Change from baseline at 12 months were analyzed using mixed model analysis. | Posted | Least Squares Mean | Standard Error | pg/mL | 12 months post-implantation |
|
Adverse device effects (ADEs), serious adverse device effects (SADEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs) were summarized for subjects enrolled in this trial as number of events, the number and percentage of subjects with events and event rate as number of events/subject-month. Adverse event data were collected during the 1-year follow-up period.
Serious Adverse Events listed below are either device-related (SADEs) or non-device related (SAEs), as denoted by the numbered subscripts. No UADEs were reported in the Randomized Arm and Single Arm adjudicated as such by the Clinical Events Committee (CEC).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized Arm - Treatment Group | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. | 40 | 497 | 283 | 497 | 15 | 497 |
| EG001 | Randomized Arm - Control Group | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. | 37 | 503 | 272 | 503 | 20 | 503 |
| EG002 | Single Arm | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Total efficacy population includes implanted subjects not belonging to a qualifying group. | 190 | 1,358 | 820 | 1,358 | 33 | 1,358 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hemorrhagic Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Splenic Infarction | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Angina Pectoris | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Angina Unstable | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Aortic Valve Disease | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Atrioventricular Block Complete | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Aneurysm | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Arrest | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Failure | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Failure Chronic | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Cardiac Perforation | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Pseudoaneurysm | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Tamponade | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Valve Disease | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiogenic Shock | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiorenal Syndrome | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypertensive Heart Disease | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Intracardiac Thrombus | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Ischemic Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Mitral Valve Disease | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Mitral Valve Incompetence | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Myocardial Infarction | Cardiac disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Myocardial Ischemia | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pericardial Effusion | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Prinzmetal Angina | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Restrictive Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Right Ventricular Failure | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Shone Complex | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vertigo Positional | Ear and labyrinth disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Abdominal Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Colitis Ischemic | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Colonic Stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Enterocutaneous Fistula | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Esophageal Achalasia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Esophageal Ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Esophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastritis Hemorrhagic | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastrointestinal Necrosis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hemorrhoidal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Intestinal Ischemia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pancreatic Mass | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pancreatitis Acute | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pneumatosis Intestinalis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Proctitis | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Retroperitoneal Hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Spigelian Hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Accidental Death | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Adverse Drug Reaction | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Catheter Site Hematoma | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Catheter Site Hematoma | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Catheter Site Hemorrhage | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Catheter Site Hemorrhage | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Chest Pain | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Chest Pain | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Device Deployment Issue | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Device Dislocation | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Device Dislocation | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Device Electrical Impedance Issue | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Device Information Output Issue | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Device malfunction | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Edema Peripheral | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Generalized Edema | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypothermia | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Impaired Healing | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Implant Site Hemorrhage | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Multi-Organ Failure | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Polyp | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Sudden Cardiac Death | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Systemic Inflammatory Response Syndrome | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Thrombosis In Device | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Ulcer | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Unintentional Medical Device Removal By Patient | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Unknown Event Leading to Death | General disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Unknown Event Leading to Death | General disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Acute Hepatic Failure | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Bile Duct Stone | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatic Cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatic Function Abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatitis Acute | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Ischemic Hepatitis | Hepatobiliary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Heart Transplant Rejection | Immune system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Abdominal Abscess | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Anal Abscess | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Central Nervous System Abscess | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Chest Wall Abscess | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Clostridial Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Clostridium Difficile Colitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Corona Virus Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Endocarditis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gangrene | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastrointestinal Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Herpes Zoster | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Implant Site Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Intervertebral Discitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Mycotic Aneurysm | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Parotitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Perineal Abscess | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pneumonia Parainfluenza Viral | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pneumonia Viral | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Postoperative Wound Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Rocky Mountain Spotted Fever | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Septic Shock | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Staphylococcal Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tracheobronchitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Urinary Tract Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vestibular Neuronitis | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Wound Infection | Infections and infestations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Arterial Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Blood Creatinine Increased | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gastrointestinal Disorder Postoperative | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Head Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Iliotibial Band Syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Multiple Fractures | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Open Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Post Laminectomy Syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Post Procedural Hemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Post Procedural Oedema | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Postoperative Thoracic Procedure Complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Rib Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Snake Bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Sternal Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Subdural Hematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tendon Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tibia Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Toxicity to Various Agents | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Traumatic Arthropathy | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Traumatic Intracranial Hemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vaccination Complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Anticoagulation Drug Level Below Therapeutic | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Blood Magnesium Decreased | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Device Function Test | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| International Normalized Ratio Decreased | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| International Normalized Ratio Increased | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Left Ventricular End-Diastolic Pressure Increased | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Transaminases Increased | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Troponin Increased | Investigations | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypovolemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Ketosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lactic Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Compartment Syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Polymyalgia Rheumatica | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Biliary Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Colorectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Esophageal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatic Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Mantle Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pancreatic Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Prostate Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Small Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Small Cell Lung Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| CNS Ventriculitis | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Carotid Artery Stenosis | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cerebral Hemorrhage | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cerebrovascular Accident | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cerebrovascular Disorder | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cervical Cord Compression | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cervicogenic Headache | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Complicated Migraine | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dementia | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dementia with Lewy Bodies | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Diabetic Neuropathy | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hemiparesis | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hemorrhage Intracranial | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hepatic Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypoesthesia | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| IIIrd (Third) Nerve Paralysis | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Metabolic Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Myoclonus | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Orthostatic Tremor | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Partial Seizures | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Renal Failure | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Subarachnoid Hemorrhage | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Transient Ischemic Attack | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vascular Dementia | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vertebral Artery Stenosis | Nervous system disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Confusional State | Psychiatric disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hallucination | Psychiatric disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Mental Disorder | Psychiatric disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Mental Status Changes | Psychiatric disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Azotemia | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Calculus Ureteric | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hematuria | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Obstructive Uropathy | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Polyuria | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Renal Failure Chronic | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Renal Impairment | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Urinary Retention | Renal and urinary disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Uterovaginal Prolapse | Reproductive system and breast disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vaginal Hemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Chronic Respiratory Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Idiopathic Pulmonary Fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Laryngeal Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Laryngeal Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pickwickian Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pulmonary Alveolar Hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Pulmonary Sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Sleep Apnea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tracheal Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Tracheomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Substance Use | Social circumstances | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Aneurysm | Surgical and medical procedures | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Aortic Valve Replacement | Surgical and medical procedures | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Pacemaker Battery Replacement | Surgical and medical procedures | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Cardiac Pacemaker Replacement | Surgical and medical procedures | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Implantable Defibrillator Insertion | Surgical and medical procedures | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Aortic Aneurysm | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Aortic Stenosis | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Arteriosclerosis | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Bleeding Varicose Vein | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Blood Pressure Fluctuation | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Embolism | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Embolism | Vascular disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Extremity Necrosis | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hematoma | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hematoma | Vascular disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Hemorrhage | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypertensive Crisis | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypertensive Emergency | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Hypovolemic Shock | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Lymphoedema | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Peripheral Vascular Disorder | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Shock | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Shock Hemorrhagic | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Subclavian Artery Stenosis | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Thrombosis | Vascular disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Varicose Ulceration | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Venous Insufficiency | Vascular disorders | MedDRA | Systematic Assessment | Non-device-related serious adverse events (SAEs) |
|
| Vessel Perforation | Vascular disorders | MedDRA | Systematic Assessment | Serious Adverse Device Affects (SADEs) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Catheter Site Hematoma | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Catheter Site Hemorrhage | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Device Deployment Issue | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Device Dislocation | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Device Information Output Issue | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Device Malfunction | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Vessel Puncture Site Pain | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Arterial Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Vascular Access Complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
| Catheter Site Pain | General disorders | MedDRA | Systematic Assessment | Non-serious Adverse Device Effects (ADEs) |
|
The COVID-19 pandemic affected the GUIDE-HF Randomized Arm study. The impact of COVID-19 on the primary endpoint and components was addressed through sensitivity analyses.
Single Arm Total Efficacy Population includes implanted subjects not belonging to a qualifying criteria group.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fei San Lee, PhD, Sr Clinical Research Scientist | Abbott | 925-694-2109 | feisan.lee@abbott.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2020 | Mar 31, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D054143 | Heart Failure, Systolic |
| D054144 | Heart Failure, Diastolic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
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| OG001 | Randomized Arm - Control Group [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Randomized Arm - Control Group (Pre-COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG002 | Randomized Arm - Treatment Group (During COVID-19) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG003 | Randomized Arm - Control Arm (During COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
|
|
| OG001 | Randomized Arm - Control Group [Excluding COVID-19 Related Events] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
|
|
| OG001 | Single Arm - Previous HF Hospitalization Only (Pre-COVID-19) | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP Only (During COVID-19) | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Previous HF Hospitalization Only (During COVID-19) | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
|
|
All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related or Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related or Possibly Related Events] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Randomized Arm - Control Group [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Randomized Arm - Control Group (Pre-COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG002 | Randomized Arm - Treatment Group (During COVID-19) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG003 | Randomized Arm - Control Arm (During COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| Randomized Arm - Control Group [Excluding COVID-19 Related Events] |
Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Randomized Arm - Treatment Group (During COVID-19) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG003 | Randomized Arm - Control Arm (During COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| Randomized Arm - Control Group [Pre-COVID] |
Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System.
All subjects will receive a CardioMEMS™ HF System.
CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Subjects with follow-up ending prior to COVID-19.
| OG002 | Randomized Arm - Treatment Group (During COVID-19) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG003 | Randomized Arm - Control Arm (During COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Randomized Arm - Treatment Group (During COVID-19) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG003 | Randomized Arm - Control Arm (During COVID-19) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Randomized Arm - Treatment Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group [Excluding COVID-19 Related or Possibly Related Events] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Randomized Arm - Control Group (6 Month) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group (12 Month) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group (12 Month) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Randomized Arm - Control Group (Baseline) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG002 | Randomized Arm - Treatment Group (6 Month) [Pre-COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG003 | Randomized Arm - Control Group (6 Month) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG004 | Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG005 | Randomized Arm - Control Group (12 Month) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG006 | Randomized Arm - Treatment Group (Baseline) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG007 | Randomized Arm - Control Group (Baseline) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG008 | Randomized Arm - Treatment Group (6 Month) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG009 | Randomized Arm - Control Group (6 Month) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG010 | Randomized Arm - Treatment Group (12 Month) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG011 | Randomized Arm - Control Group (12 Month) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Randomized Arm - Treatment Group (12 Month) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group (12 Month) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Randomized Arm - Control Group (Baseline) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG002 | Randomized Arm - Treatment Group (6 Month) [Pre-COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG003 | Randomized Arm - Control Group (6 Month) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG004 | Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG005 | Randomized Arm - Control Group (12 Month) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG006 | Randomized Arm - Treatment Group (Baseline) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG007 | Randomized Arm - Control Group (Baseline) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG008 | Randomized Arm - Treatment Group (6 Month) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG009 | Randomized Arm - Control Group (6 Month) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG010 | Randomized Arm - Treatment Group (12 Month) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG011 | Randomized Arm - Control Group (12 Month) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Randomized Arm - Treatment Group (12 Month) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group (12 Month) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System.
All subjects will receive a CardioMEMS™ HF System.
CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Subjects with follow-up ending prior to COVID-19.
| OG002 | Randomized Arm - Treatment Group (6 Month) [Pre-COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG003 | Randomized Arm - Control Group (6 Month) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG004 | Randomized Arm - Treatment Group (12 Month) [Pre-COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG005 | Randomized Arm - Control Group (12 Month) [Pre-COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG006 | Randomized Arm - Treatment Group (Baseline) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG007 | Randomized Arm - Control Group (Baseline) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG008 | Randomized Arm - Treatment Group (6 Month) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG009 | Randomized Arm - Control Group (6 Month) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG010 | Randomized Arm - Treatment Group (12 Month) [During COVID-19] | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG011 | Randomized Arm - Control Group (12 Month) [During COVID-19] | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG001 | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| Single Arm - Previous HF Hospitalization Only (Pre-COVID-19) |
All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP Only (During COVID-19) | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Previous HF Hospitalization Only (During COVID-19) | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID-19 Related or Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Previous HF Hospitalization Only [Exclude COVID-19 Related or Possibly Related Events] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG001 | Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Prior to COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Pre-COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG004 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Exclude COVID Related Events] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related/Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related/Possibly Related Events] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HFH [Exclude COVID Related/Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| Single Arm - Previous HF Hospitalization Only [Prior to COVID-19] |
All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Prior to COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System.
Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System.
CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Subjects with follow-up ending prior to COVID-19.
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Pre-COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG004 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Exclude COVID Related Events] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related/Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related/Possibly Related Events] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HFH [Exclude COVID Related/Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Prior to COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System.
Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System.
CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
Subjects with follow-up ending prior to COVID-19.
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Pre-COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending prior to COVID-19. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG004 | Single Arm - Previous HF Hospitalization Only [During COVID-19] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [During COVID-19] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. Subjects with follow-up ending during COVID-19. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [Exclude COVID Related Events] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [Exclude COVID Related/Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [Exclude COVID Related/Possibly Related Events] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HFH [Exclude COVID Related/Possibly Related Events] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Randomized Arm - Treatment Group (12 Month) | Management of subjects based on pulmonary artery (PA) pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Randomized Arm - Control Group (12 Month) | Management of subjects per standard of care (signs, symptoms, weight etc.) without knowledge of PA pressure information derived from the CardioMEMS™ HF System. All subjects will receive a CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [6 Month] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [12 Month] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [6 Month] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG003 | Single Arm - Elevated NT-proBNP/BNP Only [12 Month] | All subjects had prior elevated NT-proBNP/BNP only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG004 | Single Arm - Previous HF Hospitalization Only [12 Month] | All subjects had prior HF hospitalization only and successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
| OG005 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization [12 Month] | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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| OG002 | Single Arm - Elevated NT-proBNP/BNP and Previous HF Hospitalization | All subjects had prior elevated NT-proBNP/BNP and HF hospitalization with successful implant of CardioMEMS™ HF System. Management of subjects based on PA pressure information derived from the CardioMEMS™ HF System. CardioMEMS™ HF System: The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF. |
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