Corheart 6 LVAS Clinical Investigation

Inclusion Criteria: * Age ≥ 18 years and ≤ 75 years * The patient has signed an Informed Consent Form * Body Surface Area (BSA) ≥ 1.2 m2 * New York Heart Association (NYHA) Class IV * Left Ventricular Ejection Fraction (LVEF) ≤ 25% * Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following: * \- - a. Unable to exercise for HF, or if able to perform cardiopulmonary testing, with peak VO2 \<12 mL/kg/min and/or \< 50% predicted value; * \- - b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP \> 20 mmHg and SBP \< 90 mmHg or CI \< 2.0 L/min/m2). * \- - c. Impella or IABP assisted; Inotrope dependent/unable to wean from inotropes. Exclusion Criteria: * Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.) * Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status. * Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II. * 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 left ventricular assist system management. * Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator. * Presence of an active, uncontrolled infection. * Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure: * \- - a. Total bilirubin \> 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score. * \- - b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, or FEV1 \< 50% predicted. * \- - c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention. * \- - d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\> 70%) carotid artery stenosis * \- - e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis. * \- - f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration. * Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis. * Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant. * History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter. * Uncontrollable ventricular tachyarrythmias / ventricular fibrillation (VF). * STEMI \<2 weeks before planned implantation. * Right ventricular failure as defined by one or more of the following: * \- - a. Severe depressed RV function in echocardiography * \- - b. TAPSE \< 1.0 cm * \- - c. CVP/PCWP ratio \> 0.63 * Planned Bi-VAD support prior to enrollment. * Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function. * History of any organ transplant. * Pre albumin \< 150 mg/L, or Albumin \< 30g/L (3 g/dL). * Any condition other than HF that could limit survival to less than 24 months * Positive pregnancy test if of childbearing potential. * Lactating mothers. * Participation in any other clinical investigation that is likely to confound study results or affect the study. * Patients who have been placed in an institution by court order or by order of the authorities.