HeartMate 3™ CE Mark Clinical Investigation Plan
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Advanced Refractory Left Ventricular Heart Failure
- Sponsor
- Abbott Medical Devices
- Enrollment
- 50
- Locations
- 10
- Primary Endpoint
- Survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical study will be conducted in multiple countries. The clinical study will be conducted in compliance with the Declaration of Helsinki, ICH/GCP and EN ISO 14155:2011 Requirements for Clinical Investigations and in accordance with country-specific requirements, under one clinical study protocol.
This study will evaluate the performance of the HM3 LVAS, side effects and undesirable conditions within acceptable risks and weigh them against the intended performance of HM3 LVAS in accordance with Essential Requirements 2, 5 and 16 of the Active Implantable Medical Device Directive 90/385/EEC (AIMDD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient or legal representative has signed Informed Consent Form (ICF)
- •Age ≥ 18 years
- •BSA ≥ 1.2 m2
- •NYHA IIIB or IV OR ACC/AHA Stage D
- •CI ≤ 2.2 L/min/m2, while not on inotropes
- •Patients must also meet one of the following:
- •On Optimal Medical Management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond,
- •In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days,
- •Inotrope dependent/unable to wean from inotropes
- •Listed for Transplant
Exclusion Criteria
- •Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
- •Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
- •Existence of ongoing mechanical circulatory support (MCS) other than IABP
- •Positive pregnancy test if of childbearing potential
- •Lactating mothers
- •Presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of LVAD implant
- •History of any organ transplant
- •Platelet count \< 100,000 x 103/L (\< 100,000/ml)
- •Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
- •History of confirmed, untreated AAA \> 5 cm in diameter
Outcomes
Primary Outcomes
Survival
Time Frame: 6 months
Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data
Secondary Outcomes
- Functional Status - New York Heart Association (NYHA) Classification(Baseline, Month 1, Month 3, Month 6)
- Rehospitalizations(As they occurred, Baseline through 180 Days)
- Stroke Free Survival(6 months)
- All Adverse Events(As they occurred, Baseline through 180 Days)
- Quality of Life (EQ-5D-5L)(Baseline, Month 1, Month 3, Month 6)
- Device Malfunctions(As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome)
- Reoperations(As they occurred, Baseline through 180 Days)
- Functional Status - Six Minute Walk Test (6MWT)(Baseline, Month 1, Month 3, Month 6)