Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System

Inclusion Criteria:

The following is a list of general inclusion criteria:

• Age ≥ 18 years

• Left Ventricular Ejection Fraction (LVEF) < 30%

• NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure

• Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes

• Patient is able to provide written informed consent

• More detailed inclusion criteria information is noted in the study protocol

Exclusion Criteria:

1. Etiology of heart failure due to or associated with uncorrected thyroid disease,obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictivecardiomyopathy

2. Technical obstacles which pose an inordinately high surgical risk

3. Existence of ongoing mechanical circulatory support (MCS) other than IABP andImpella 5.0 or 5.5

4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) andelevated LDH equal or greater than 600 IU/L.

5. Positive pregnancy test if of childbearing potential

6. Presence of mechanical aortic cardiac valve that will not be either converted to abioprosthesis

7. History of any organ transplant

8. Platelet count <100,000/mL

9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocialissues

10. History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameterwithin 6 months of enrollment

11. Presence of an active, uncontrolled infection

12. Intolerance to anticoagulant or antiplatelet therapies or any otherperi/postoperative therapy that the investigator will require based upon thepatient's health status

13. Presence of remarkable pre-defined end-organ dysfunction.

14. Patient has moderate to severe aortic insufficiency without plans for correctionduring pump implant

15. Low albumin - removed from recent exclusion criteria

16. Planned Bi-VAD support prior to enrollment

17. Patient has known hypo- or hyper coagulable state such as disseminated intravascularcoagulation and heparin induced thrombocytopenia (HIT)

18. Participation in any other clinical investigation that is likely to confound studyresults or affect the study

19. Any condition other than heart failure that could limit survival to less than 24months

20. Patients refusing blood transfusion