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:

Etiology of heart failure 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
Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella 5.0 or 5.5
Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and elevated LDH equal or greater than 600 IU/L.
Positive pregnancy test if of childbearing potential
Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis
History of any organ transplant
Platelet count <100,000/mL
Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues
History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
Presence of an active, uncontrolled infection
Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy that the investigator will require based upon the patient's health status
Presence of remarkable pre-defined end-organ dysfunction.
Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
Low albumin - removed from recent exclusion criteria
Planned Bi-VAD support prior to enrollment
Patient has known hypo- or hyper coagulable state such as disseminated intravascular coagulation and heparin induced thrombocytopenia (HIT)
Participation in any other clinical investigation that is likely to confound study results or affect the study
Any condition other than heart failure that could limit survival to less than 24 months
Patients refusing blood transfusion