Study for Evaluating the EVAHEART?2 LVAS: the COMPETENCE Trial (COMPETENCE)

This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).

Adult (>18 years old), advanced heart failure NYHA Class III with dyspnea upon mild physical activity or Class IV patients who are refractory to advanced heart failure management and meet study Inclusion/Exclusion criteria will be enrolled.

The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory advanced heart failure.

Subjects will be followed for 6 months (short-term cohort) and 24 months (long-term cohort) after EVA2/HM3 LVAS implantation or until outcome events of transplantation, explantation, death or withdrawal, whichever occurs first. Whereas subjects experiencing the outcome events of "Severe RHF" and "Disabling stroke" will remain in study follow-up.

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 restrictive cardiomyopathy

2. Technical obstacles which pose an inordinately high surgical risk

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

4. Ongoing Impella (5. 0 or 5. 5. presenting related clinical sign (i.e. hematuria) and elevated 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 a bioprosthesis

7. History of any organ transplant

8. Platelet count 5 cm in diameter within 6 months of enrollment

9. Presence of an active, uncontrolled infection

10. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative

therapy that the investigator will require based upon the patient's health status

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

2. Patient has moderate to severe aortic insufficiency without plans for correction

during pump implant

1. Low albumin * removed from recent exclusion criteria

2. Planned Bi-VAD support prior to enrollment

3. Patient has known hypo* or hyper coagulable state such as disseminated intravascular

coagulation and heparin induced thrombocytopenia (HIT)

1. Participation in any other clinical investigation that is likely to confound study

results or affect the study

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

months

1. Patients refusing blood transfusion