Corheart 6 LVAS Study

Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.

The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.

Inclusion Criteria:

• 1. Age ≥ 18 years and ≤ 75 years
• 2. The patient has signed an Informed Consent Form
• 3. Body Surface Area (BSA) ≥ 1.2 m^2
• 4. New York Heart Association (NYHA) Class IV
• 5. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
• 6. 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;
• d. Inotrope dependent/unable to wean from inotropes.

Exclusion Criteria:

• 1. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
• 2. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
• 3. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
• 4. Platelet count < 100,000 x 10^3/L (< 100,000/ml).
• 5. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
• 6. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• 7. Presence of an active, uncontrolled infection.
• 8. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• a. Total bilirubin > 51.3 μmol/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 ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
• f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• 9. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
• 10. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
• 11. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• 12. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
• 13. STEMI <2 weeks before planned implantation.
• 14. 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
• 15. Planned Bi-VAD support prior to enrollment.
• 16. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
• 17. History of any organ transplant.
• 18. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
• 19. Any condition other than HF that could limit survival to less than 24 months.
• 20. Positive pregnancy test if of childbearing potential.
• 21. Lactating mothers.
• 22. Participation in any other clinical investigation that is likely to confound study results or affect the study.
• 23. Patients who have been placed in an institution by court order or by order of the authorities.