Corheart 6 LVAS Study

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 patientmust 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, typeII pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not toinadequately low ventricular filling pressure (PCWP > 20 mmHg and SBP < 90 mmHg orCI < 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 otherperi/post-operative therapy the investigator will require based upon thepatients' health status.

3. Patient has known hypo or hyper coagulable states such as disseminatedintravascular 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 orpsychosocial issues that are likely to impair compliance with the studyprotocol and ventricular assist system management.

6. Technical obstacles which pose an inordinately high surgical risk, in thejudgment of the investigator.

7. Presence of an active, uncontrolled infection.

8. Presence of any one of the following risk factors for indications of severe endorgan dysfunction or failure:

• a. Total bilirubin > 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy provenliver cirrhosis, or clinically Child-Pugh B and C score.

• b. History of severe chronic obstructive pulmonary disease (COPD) defined byFEV1/FVC < 0.7, or FEV1 < 50% predicted.

• c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that isunresponsive to pharmacologic intervention.

• d. History of stroke within 180 days prior to enrollment, or a history ofcerebrovascular 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 orextremity ulceration.

9. Etiology of heart failure (HF) due to or associated with uncorrected thyroiddisease, obstructive/ restrictive cardiomyopathy, pericardial disease,amyloidosis or giant cell myocarditis.

10. Uncorrected moderate to severe aortic insufficiency without plans forcorrection during pump implant.

11. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracicaortic 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 confoundstudy results or affect the study.

23. Patients who have been placed in an institution by court order or by order ofthe authorities.