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This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions
The study is an observational, single group study where all participants receive the same intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as standard of care. After enrollment into the study, the patient will be followed until six month follow up completion. The objective of this clinical investigation is to understand the role of hemodynamic monitoring in LVAD patients and:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Patients with CardioMEMS PA Sensor and HeartMate LVAD prior to study enrollment | Patients with CardioMEMS PA Sensor and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS HF System |
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| Group B: Patients with existing HeartMate LVAD implanted with CardioMEMS PA Sensor post enrollment | Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, will receive hemodynamic management using CardioMEMS HF System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemodynamic management using CardioMEMS HF System | Device | Using the CardioMEMS HF System, clinicians will treat to target PA pressure ranges |
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| Measure | Description | Time Frame |
|---|---|---|
| Six Minute Hall Walk (6MHW) Distance | Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. | Six Months |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in PA Diastolic Pressure From Baseline to 6 Months | Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up. | six months |
| Days PA Diastolic Pressure is in the Pre-specified Target Range |
Inclusion Criteria:
Exclusion Criteria:
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Heart Failure patients will be recruited from the clinicians practice based on the presence of both devices under study
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| Name | Affiliation | Role |
|---|---|---|
| Kartik Sundareswaran | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Health | La Jolla | California | 92037 | United States | ||
| USC University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37079511 | Derived | Thohan V, Abraham J, Burdorf A, Sulemanjee N, Jaski B, Guglin M, Pagani FD, Vidula H, Majure DT, Napier R, Heywood TJ, Cogswell R, Dirckx N, Farrar DJ, Drakos SG; INTELLECT 2-HF Investigators. Use of a Pulmonary Artery Pressure Sensor to Manage Patients With Left Ventricular Assist Devices. Circ Heart Fail. 2023 Jun;16(6):e009960. doi: 10.1161/CIRCHEARTFAILURE.122.009960. Epub 2023 Apr 20. |
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The study enrolled a total of 101 subjects at 22 investigational sites in the United States. The first subject was enrolled on 24 August 2017 and enrollment was completed on 20 August 2019. The last 6-month follow-up was completed on 6 March 2020. Data was collected until the database closure date, 3 April 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Patients with both a CardioMEMS PA Sensor and HeartMate II or HeartMate 3 Left Ventricular Assist Device (LVAD) previously implanted, will receive hemodynamic management guided using hemodynamic data as measured by the CardioMEMS HF System |
| FG001 | Group B |
| 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_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 18, 2018 |
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Average number of days PA diastolic pressure was in the pre-specified target range of 8-15 mmHg. For this measure, both arms were combined to assess the mean number of days, all study subjects spent in the target PA diastolic range. This was pre-defined as a whole population analysis.
| six months |
| PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test. | 6 months |
| Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions | Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD. This measure is independent of study arm as both patients had both devices at enrollment. This was pre-defined as a whole population analysis. | six months |
| New York Heart Association (NYHA) Classification | Change in NYHA classification from baseline assessed at 6 months. New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | six months |
| EQ-5D-5L VAS | Health related quality of life (EQ-5D-5L). The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. For this measure, both arms were combined to assess the mean of and changes to the EQ-5D-5L VAS for all study subjects, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis. | six months |
| Number and Percent of Participants With All-cause Hospitalizations. | Number and percent of participants who were hospitalized for any cause during follow-up. | six months |
| Number and Percent of Participants With Worsening Heart Failure Events | Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management. | six months |
| Los Angeles |
| California |
| 90033 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| San Diego Cardiac | San Diego | California | 92123 | United States |
| California Pacific Medical Center - Van Ness Campus | San Francisco | California | 94109 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| The Nebraska Medical Center | Omaha | Nebraska | 68105 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27607 | United States |
| University of North Carolina | Raleigh | North Carolina | 27607 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio Sate University | Columbus | Ohio | 43210 | United States |
| Providence Heart and Vascular Institute | Portland | Oregon | 97225 | United States |
| Palmetto Health Richland | Columbia | South Carolina | 29203 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| Aurora Medical Center | Milwaukee | Wisconsin | 53215 | United States |
Patients with a HeartMate II or HeartMate 3 LVAD previously implanted who are implanted with a CardioMEMS PA Sensor within 72 hours of enrollment, will receive hemodynamic management guided using hemodynamic data as measured by the CardioMEMS HF System. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS Hemodynamic management using CardioMEMS: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges |
| BG001 | Group B | Patients with LVAD to implant CardioMEMS device within 72 hours of enrollment, will receive hemodynamic management using CardioMEMS Hemodynamic management using CardioMEMS: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Ischemic Cardiomyopathy | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Systemic Systolic Pressure | Systemic Systolic Pressure was not acquired from all patients at baseline. | Mean | Standard Deviation | mmHg |
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| Systemic Diastolic Pressure | Systemic Diastolic Pressure was not acquired from all patients at baseline. | Mean | Standard Deviation | mmHg |
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| Heart Rate | Heart Rate was not acquired from all patients at baseline. | Mean | Standard Deviation | beats per minute |
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| NYHA Functional Class | New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | Count of Participants | Participants |
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| Six Minute Walk Distance | Six Minute Hall Walk was not acquired from all patients at baseline. | Mean | Standard Deviation | meters |
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| EQ-5D-5L VAS | The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. | EQ-5D-5L VAS test was not obtained from all patients at baseline. | Mean | Standard Deviation | score on a scale |
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| 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 | Six Minute Hall Walk (6MHW) Distance | Change in 6MHW distance compared to baseline. The six-minute hall walk (6MHW) test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. | Six minute hall walk distance measured at 6 months compared to baseline. | Posted | Mean | Standard Deviation | meters | Six Months |
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| Other Pre-specified | Change in PA Diastolic Pressure From Baseline to 6 Months | Changes in PA diastolic pressure measurement over time from baseline to 6 months follow-up. | Change in PA Diastolic pressure from baseline to 6 months. | Posted | Mean | Standard Deviation | mmHg | six months |
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| Other Pre-specified | Days PA Diastolic Pressure is in the Pre-specified Target Range | Average number of days PA diastolic pressure was in the pre-specified target range of 8-15 mmHg. For this measure, both arms were combined to assess the mean number of days, all study subjects spent in the target PA diastolic range. This was pre-defined as a whole population analysis. | Posted | Mean | Standard Deviation | days | six months |
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| Other Pre-specified | PA Diastolic Pressure Before 6MHW Test to After 6MHW Test | Pulmonary Artery Diastolic Pressure collected using the CardioMEMS-HF system before and after the 6MHW test. | Posted | Mean | Standard Deviation | mmHg | 6 months |
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| Other Pre-specified | Number of Subjects With Either CardioMEMS or HeartMate Device Malfunctions | Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD. This measure is independent of study arm as both patients had both devices at enrollment. This was pre-defined as a whole population analysis. | All patients with LVAD and CardioMEMS device in place. | Posted | Count of Participants | Participants | six months |
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| Other Pre-specified | New York Heart Association (NYHA) Classification | Change in NYHA classification from baseline assessed at 6 months. New York Heart Association (NYHA) Functional Classification stratifies patients' heart failure (HF) by the severity of their symptoms. I - No limitation of physical activity. II - Slight limitation of physical activity. Comfortable at rest. III - Marked limitation of physical activity. Comfortable at rest. IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. | NYHA class as a continuous variable in which the change in NYHA class is calculated using: NYHA class I =1, class II = 2, class IIIa/IIIb = 3, class IV = 4 and death =5. | Posted | Least Squares Mean | 95% Confidence Interval | Change in NYHA Class | six months |
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| Other Pre-specified | EQ-5D-5L VAS | Health related quality of life (EQ-5D-5L). The EQ-5D-5L self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life. For this measure, both arms were combined to assess the mean of and changes to the EQ-5D-5L VAS for all study subjects, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis. | Change in EQ-5D-5L VAS scores from baseline to 6 months. | Posted | Least Squares Mean | 95% Confidence Interval | Change in score | six months |
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| Other Pre-specified | Number and Percent of Participants With All-cause Hospitalizations. | Number and percent of participants who were hospitalized for any cause during follow-up. | Posted | Count of Participants | Participants | six months |
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| Other Pre-specified | Number and Percent of Participants With Worsening Heart Failure Events | Worsening HF events incudes emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management. | Posted | Count of Participants | Participants | six months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Patients with both an LVAD and CardioMEMS device in place. All safety assessments were made on a population basis, as all subjects were treated the same and had the same devices once enrolled. This was pre-defined as a whole population analysis. | 7 | 101 | 36 | 101 | 3 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Heart Failure | Cardiac disorders | Systematic Assessment | Worsening Heart Failure |
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| Syncope/presyncope/dizziness and hypovolemia | Cardiac disorders | Systematic Assessment | Syncope/presyncope/dizziness and hypovolemia |
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| Cardiac arrhythmias | Cardiac disorders | Systematic Assessment | Cardiac arrhythmias |
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| Right heart failure | Cardiac disorders | Systematic Assessment | Right heart failure |
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| Renal dysfunction secondary to heart failure | Renal and urinary disorders | Systematic Assessment | Renal dysfunction secondary to heart failure |
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| Other neurological event | Nervous system disorders | Systematic Assessment | Other neurological event |
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| Respiratory failure secondary to cardiovascular cause | Vascular disorders | Systematic Assessment | Respiratory failure secondary to cardiovascular cause |
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| Strokes regardless of their type and etiology | Nervous system disorders | Systematic Assessment | Strokes regardless of their type and etiology |
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| Other | General disorders | Systematic Assessment | Other |
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| Pneumonia | Infections and infestations | Systematic Assessment | Pneumonia |
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| Hypotension | Cardiac disorders | Systematic Assessment | Hypotension |
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| Over-diuresis | Renal and urinary disorders | Systematic Assessment | Over-diuresis |
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| Volume Overload | Cardiac disorders | Systematic Assessment | Volume Overload |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious Adverse Device Effects | Cardiac disorders | Systematic Assessment | Events were classified by organ class only for non-serious adverse device effects. |
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No limitations or caveats to disclose for this study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marie-Elena Brett, PhD; Principal Scientist Clinical Research | Abbott_Medical_Devices | 17815283613 | marieelena.brett@abbott.com |
| Feb 12, 2021 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| NYHA Class II |
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| NYHA Class III |
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| NYHA Class IV |
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Group B: Patients with existing HeartMate LVAD at enrollment who were implanted with CardioMEMS PA Sensor post enrollment. Patients with a HeartMate LVAD prior to study enrollment who are implanted with a CardioMEMS PA Sensor within 72 hours of study enrollment, received hemodynamic management using CardioMEMS HF System. |
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