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).
Who can participate
Age range18 Years
SexALL
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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
✓. LVEF ≤ 25%
✓. CI ≤ 2.2 L/min/m2, while not on inotropes
✓. Patients must also meet one of the following:
✓. Females of child bearing age must agree to use adequate contraception
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