CorWave LVAS FIH Study

Inclusion Criteria: * Subject or legal representative has signed Informed Consent Form * Age \> 18 and \< 75 years old * Body Surface Area (BSA) ≥ 1.2 m2 * Left Ventricular Ejection Fraction (LVEF) ≤ 35% * Inotrope dependent OR * Cardiac Index (CI) \< 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following criteria: * On Guideline Directed Medical Therapy (GDMT) for at least 45 out of the last 60 days and are failing to respond. * Advanced heart failure (Class III or Class IV for at least 14 days AND support from short term mechanical circulatory support for up to 7 days). * Females of childbearing age must agree to use adequate contraception. * Patient must be eligible for heart transplantation. Exclusion Criteria: * Heart failure (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 * Ongoing mechanical circulatory support (MCS) other than IABP or micro axial pumps * INTERMACS Class I patients * Subject is on a ventilator * Subject is pregnant or breastfeeding * Presence of a mechanical aortic valve that will not be converted to a bioprosthesis at the time of LVAD implant * History of any organ transplant * Platelet count \< 100,000/μl * Psychiatric disease/disorder, illicit drug use, irreversible cognitive dysfunction or psychosocial is…