Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation

The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and
will be compared to the HeartMate II and HVAD devices.

Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD
System (treatment group) or control group (HeartMate II and HVAD). The physician will have
the option to choose which control device to implant.

The primary objective of the study is to show non-inferiority of the HeartAssist 5®
(treatment group) to the control group.

Inclusion Criteria:

1. Able to sign Informed Consent.

2. Age ≥ 18

3. Body Surface Area (BSA) ≥ 1.2 m2.

4. Cardiac transplant candidate, defined as: Listed for cardiac transplant, and
designated by the institution's multidisciplinary transplant committee as appropriate
forLVAD Bridge-to-Transplantation therapy, or Designated by the institutions's
multidisciplinary transplant committee as: 1) an appropriate candidate for LVAD
Bridge-to transplant therapy, and 2) An inappropriate candidate for LVAD destination
therapy

5. LVAD implantation has been approved by the institution's multidisciplinary transplant
committee.

6. Patient is NYHA Class IV.

7. Able to return to the clinical site for all routine follow up visits.

Exclusion Criteria:

1. Cardiothoracic surgery within 30 days prior to enrollment.

2. Acute Myocardial Infarction within 14 days prior to enrollment.

3. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or
left ventricular assist device.

4. Mechanical, animal, or human tissue heart valve.

5. History of untreated abdominal or thoracic aortic aneurysm > 5 cm.

6. On ventilator support for > 72 hours within four days immediately prior to enrollment.

7. Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).

8. Proven history of pulmonary embolism within 90 days of enrollment.

9. Moderate to severe aortic insufficiency as determined by echocardiogram without plans
for correction during pump implantation surgery.

10. Requires aortic, mitral, tricuspid or pulmonary valve replacements (including
Bioprosthetic valves) or left ventricular (LV) aneurysm resection.

11. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelets <100,000,
INR > 1.6 or PTT > 2.5 times control in the absence of anticoagulation therapy)

12. Severe right ventricular failure as defined by the anticipated need for right
ventricular assist device (RVAD) support OR extracorporeal membrane oxygenation (ECMO)
at the time of implantation OR right atrial pressure > 20 mmHg while on multiple
inotropes.

13. Significant renal dysfunction defined as > 3.5 mg/dl or requires hemo or peritoneal
dialysis for renal failure (excluding ultra-filtration for fluid removal).

14. Evidence of intrinsic hepatic disease defined as liver enzyme values (AST, ALT and LDH
that are > 3 times the upper limit of normal) OR a total bilirubin > 3 mg/dl OR biopsy
proven liver cirrhosis or portal hypertension.

15. Pregnancy

16. Active systemic infection prior to study enrollment not yet resolved by treatment.
Active Systemic Infection is defined by any one of the following in spite of
antibiotic, antiviral or antifungal treatment: 2 or more consecutive positive
cultures; elevated temperature > 37.2 (°C) and white blood cell count > 11.0 (103/ml);
hypotension, tachycardia and generalized malaise.

17. Stroke within 90 days prior to enrollment OR patient has a history of cerebral
vascular disease with > 80% extra cranial stenosis documented by carotid Doppler study
during transplant evaluation

18. Modified Rankin Scale score of ≥ 2 or has any neurologic disability as confirmed by
imaging (CT or MRI).

19. Significant lower extremity peripheral vascular disease accompanied by rest pain or
leg ulceration.

20. Intolerant to anticoagulant or antiplatelet therapies or any other peri- or
postoperative therapy that the investigator may administer based upon the patient's
health status.

21. Psychiatric disorder, or other psychosocial behavior that is likely to impair
compliance with the study protocol.

22. Receiving therapy with an investigational intervention or participating in any other
clinical investigation at the time of enrollment.

23. Condition, other than heart failure, that may limit survival to less than three (3)
years and/or would exclude cardiac transplantation.

24. Unwilling or unable to comply with any study requirement.