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The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with New York Heart Association (NYHA) Class III Heart Failure in a commercial setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardioMEMS HF System | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Device/System Related Complications | A device/System related complication (DSRC) is 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: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device. | Two year |
| Freedom From Pressure Sensor Failure. | A sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. | Two year |
| Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. | HFH events at 1 year versus the HFH events in the year prior to enrollment | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced a heart failure hospitalization within the past 12 months.
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| Name | Affiliation | Role |
|---|---|---|
| Pascal De Groote, MD | CHU de Lille - Institut Coeur Poumon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia | ||
| CHR Citadelle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41929392 | Derived | de Groote P, McKenzie S, Flett A, Foley P, Rossing K, Ciccarelli M, Pouleur AC, Gazzola C, Park E, Roubille F. Heart failure hospitalization reduction and long-term safety with remote pulmonary artery pressure monitoring: results of the CardioMEMS heart failure system outside United States (of America) post-market study. Eur Heart J Open. 2026 Apr 1;6(2):oeag021. doi: 10.1093/ehjopen/oeag021. eCollection 2026 Mar. | |
| 34882989 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Consented Population | Patients who signed the study Informed Consent |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patients who underwent a successful implant constitute the Effectiveness Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Effectiveness Population | Patients who signed the Study Informed Consent and underwent successful CardioMEMS implant |
| 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 | A device/System related complication (DSRC) is 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: 1) is treated with invasive means (other than intramuscular medication or right heart catheterization which is used for diagnostic purposes); 2) results in death of the subject; 3) results in the explant of the device. | Patients who signed the study Informed Consent and underwent CardioMEMS implant | Posted | Count of Participants | Participants | Two year |
|
2 years
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device under investigation.
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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 | Safety Population | Patients who signed the study Informed Consent and underwent CardioMEMS implant procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal heart rate or rhythm | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decompensated Heart Failure | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pascal De Groote | CHU de Lille - Institut Coeur Poumon | 33 (0)3 20 44 50 38 | Pascal.DEGROOTE@chu-lille.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2018 | Nov 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2018 | Jan 31, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Liège |
| Belgium |
| Rigshospitalet | Copenhagen | Denmark |
| CHRU de Lille | Lille | France |
| Royal Bromptom Hospital | London | United Kingdom |
| Derived |
| Cowie MR, Flett A, Cowburn P, Foley P, Chandrasekaran B, Loke I, Critoph C, Gardner RS, Guha K, Betts TR, Carr-White G, Zaidi A, Lim HS, Hayward C, Patwala A, Rogers D, Pettit S, Gazzola C, Henderson J, Adamson PB. Real-world evidence in a national health service: results of the UK CardioMEMS HF System Post-Market Study. ESC Heart Fail. 2022 Feb;9(1):48-56. doi: 10.1002/ehf2.13748. Epub 2021 Dec 9. |
| 32031758 | Derived | Cowie MR, de Groote P, McKenzie S, Brett ME, Adamson PB; CardioMEMS Post-Market Study Investigators. Rationale and design of the CardioMEMS Post-Market Multinational Clinical Study: COAST. ESC Heart Fail. 2020 Jun;7(3):865-872. doi: 10.1002/ehf2.12646. Epub 2020 Feb 7. |
| Physician Decision |
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| Not Implanted due to COVID restrictions |
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| Not implanted due to physician's decision |
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| Withdrawn Prior Implant Attempt |
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| 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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| Ischemic Cardiomyopathy | Patients with Ischemic Cardiomyopathy | Count of Participants | Participants |
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| CRT/CRT-D | Patients with Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with Defibrillation (CRT-D) | Count of Participants | Participants |
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| ICD | Patients with Implantable Cardioverter Defibrillator (ICD) | Count of Participants | Participants |
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| Preserved Ejection Fraction (EF) | Patients with Ejection Fraction higher than 40% at baseline | Count of Participants | Participants |
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| Hypertension | Patients diagnosed with hypertension at baseline | Count of Participants | Participants |
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| Diabetes Mellitus | Patients diagnosed with Diabetes Mellitus at baseline | Count of Participants | Participants |
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| Chronic obstructive pulmonary disease | Patients diagnosed with Chronic obstructive pulmonary disease at baseline | Count of Participants | Participants |
|
| Chronic kidney disease | Patients diagnosed with Chronic kidney disease at baseline are then categorized in stages (1 to 5) depending on the estimated Glomerular Filtration Rate (eGFR), Stage 1 is less serious than stage 5: stage 1: a normal eGFR above 90ml/min, but other tests have detected signs of kidney damage stage 2: a slightly reduced eGFR of 60 to 89ml/min, with other signs of kidney damage stage 3: an eGFR of 30 to 59ml/min stage 4:an eGFR of 15 to 29ml/min stage 5:an eGFR below 15ml/min, meaning the kidneys have lost almost all of their function | Only Chronic Kidney disease of stage 3, 4 and 5 were collected therefore if a patient had a CKD in stage 2, it was not reported. | Count of Participants | Participants |
|
| Glomerular filtration rate (eGFR | Glomerular filtration rate (mL/min/1.73 m2) measured at baseline | Mean | Standard Deviation | mL/min/1.73 m^2 |
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| Medications at baseline | Patient medications at baseline | Number | number of patients taking medication |
|
| NYHA Class | The New York Heart Association (NYHA) functional class helps to classify congestive heart failure patients based on their symptoms. Its classes are: Class I: No symptoms of heart failure. Class II: Symptoms of heart failure with moderate exertion, such as ambulating two blocks or two flights of stairs. Class III: Symptoms of heart failure with minimal exertion, such as ambulating one block or one flight of stairs, but no symptoms at rest. Class IV: Symptoms of heart failure at rest. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Freedom From Pressure Sensor Failure. | A sensor failure occurs when no readings can be obtained from it after troubleshooting the system to rule out any problems with the external electronics. | Posted | Count of Participants | Participants | Two year |
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| Primary | Annualized Heart Failure Hospitalization (HFH) Rate at 1 Year Compared to the HF Hospitalization Rate in the Year Prior to Enrollment. | HFH events at 1 year versus the HFH events in the year prior to enrollment | Patients who signed the Study Informed Consent and underwent successful CardioMEMS implant | Posted | Number | 95% Confidence Interval | HFH events per year | One year |
|
|
|
| 90 |
| 304 |
| 225 |
| 304 |
| 17 |
| 304 |
| Allergic reaction | General disorders | Systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
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| Decompensated Heart Failure | Cardiac disorders | Systematic Assessment |
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| Exacerbation of COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Hematoma | Blood and lymphatic system disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Thrombus | Vascular disorders | Systematic Assessment |
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| Transient ischemic attack (TIA) | Nervous system disorders | Systematic Assessment |
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| Valve Damage | Cardiac disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Hemoptisis | Vascular disorders | Systematic Assessment |
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| Lead dislodgement or migration | Product Issues | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment |
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| Abnormal heart rate or rhythm | Cardiac disorders | Systematic Assessment |
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| Pulmonary infarct | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Thrombus | Vascular disorders | Systematic Assessment |
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