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The purpose of this study is to characterize the use of the CardioMEMSâ„¢ HF System when used in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CardioMEMS HF System | Experimental | Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMS HF System | Device | Pulmonary Artery Pressure Monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Device/System Related Complications | This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant. | one year |
| Freedom From Pressure Sensor Failure | This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant. | one year |
| Percent of Successful Pulmonary Artery Pressure Data Transmissions | Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Hospitalization (HFH) Rate | Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Angermann, Prof. Dr. | Deutsches Zentrum für Herzinsuffizienz Würzburg | Principal Investigator |
| Michael Boehm, Prof. Dr. | University Hospital, Saarland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinukum Coburg | Coburg | Bavaria | 96450 | Germany | ||
| Universitätsklinikum Würzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40223608 | 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. | |
| 34738340 |
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Three of the 239 subjects enrolled withdrew before implantation was attempted. Of the 236 subjects who had an attempted implant, two subjects were not implanted. One subject was not implanted because there was a failure to meet screening criteria and the other subject experienced an AE during the implant procedure and was not implanted.
The study enrolled a total of 239 subjects at 31 investigational sites in Germany, The Netherlands, and Ireland. The first subject was enrolled on 13 May 2016 and the last subject was enrolled on 29 March 2018. The last 12-month follow-up was completed on 19 March 2019. Data was collected until the database closure date, 28 June 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | CardioMEMS HF System | Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Endpoint Analysis (First 12M) |
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| Extended Follow-Up (Until Last pt 12M) |
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| ID | Title | Description |
|---|---|---|
| BG000 | CardioMEMS HF System | Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Freedom From Device/System Related Complications | This primary safety endpoints is freedom from device/system related complications (DSRCs) which is defined as an adverse event that is, or is possibly, related to the device/system (wireless pressure sensor or external electronics) and has at least one of the following characteristics: is treated with invasive means (other than intramuscular medication or right heart cauterization which is used for diagnostic purposes); results in death of the subject; or results in the explant of the device. The pre-specified goal of this endpoint was was to have a freedom from DSRC greater than 0.80 at 12 months post-implant. | Safety population | Posted | Number | 95% Confidence Interval | percentage of patients | one year |
|
AEs were collected starting from enrollment and until the last patient completed 12 months follow-up.
Non-serious Adverse Events were not collected as part of the protocol.
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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 | CardioMEMS HF System | Subjects will collect pulmonary artery pressure measurements daily which will be used by health care professionals to adjust cardiac medications. CardioMEMS HF System: Pulmonary Artery Pressure Monitoring |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marie-Elena Brett | Abbott | 7815283613 | marieelena.brett@abbott.com |
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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 | Sep 19, 2017 | Jul 21, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Würzburg |
| Bavaria |
| 97080 |
| Germany |
| Bohm M, Assmus B, Anker SD, Asselbergs FW, Brachmann J, Brett ME, Brugts JJ, Ertl G, Wang A, Hilker L, Koehler F, Rosenkranz S, Leistner DM, Abdin A, Wintrich J, Zhou Q, Adamson PB, Angermann CE. Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring. ESC Heart Fail. 2022 Feb;9(1):155-163. doi: 10.1002/ehf2.13665. Epub 2021 Nov 4. |
| 29777373 | Derived | Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Kohler F, Rosenkranz S, Tschope C, Adamson PB, Bohm M. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19. |
| Adverse Event |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Ejection Fraction | Ejection fraction (EF) is a measurement of the percentage of blood leaving the heart each time it contracts. Heart failure patients with an EF <40% are considered to have reduced ejection fraction (HFrEF) where as patients with an EF >=40% are considered to have preserved ejection fraction (HFpEF). | Count of Participants | Participants |
|
| HF Etiology | Count of Participants | Participants |
|
|
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| Primary | Freedom From Pressure Sensor Failure | This primary safety endpoints is freedom from pressure sensor failure greater than 0.90 at 12 months post-implant. | Safety population | Posted | Number | 95% Confidence Interval | percentage of patients | one year |
|
|
|
| Primary | Percent of Successful Pulmonary Artery Pressure Data Transmissions | Patient data transmission success is defined as the percentage of successful transmissions among attempted transmissions. All subjects who were consented and implanted with a pressure sensor regardless of study completion status are included in this analysis. All attempted data transmissions through the 12-month visit or death or withdrawal are included in the analysis. For each subject, the patient data transmission success rate (% of successful transmission) was calculated as total number of successful transmissions divided by total attempted transmissions within 12 months. | All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis. | Posted | Mean | Standard Deviation | percentage of successful transmissions | one year |
|
|
|
| Secondary | Heart Failure Hospitalization (HFH) Rate | Comparison of the annualized heart failure hospitalization (HFH) rate (including recurrent events) at 12 months post-implant with the rate (including recurrent events) 12 months prior to implant. | All subjects who were consented and implanted with a pressure sensor regardless of study completion status were included in the analysis. | Posted | Number | 95% Confidence Interval | Hazard Ratio | one year |
|
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|
| 42 |
| 234 |
| 184 |
| 239 |
| 0 |
| 0 |
| Abnormal heart rate or rhythm | Cardiac disorders | Systematic Assessment |
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| Decompensated HF | Cardiac disorders | Systematic Assessment |
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| Other cardiac disorders | Cardiac disorders | Systematic Assessment |
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| Endocrine disorders | Endocrine disorders | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| General disorders | General disorders | Systematic Assessment |
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| Hepatobiliary disorders | Hepatobiliary disorders | Systematic Assessment |
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| Immune system disorders | Immune system disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Other infections and infestations | Infections and infestations | Systematic Assessment |
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| Injury, poisoning, and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Investigations | Investigations | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Other renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
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| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Surgical and medical procedures | Surgical and medical procedures | Systematic Assessment |
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| Vascular disorders | Vascular disorders | Systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Eye disorders | Eye disorders | Systematic Assessment |
|
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