MOMENTUM 3 IDE Clinical Study Protocol

The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory
left ventricular heart failure; either for short term support, such as a bridge to cardiac
transplantation (BTT) or myocardial recovery, or as long term support, such as destination
therapy (DT). The HM3 is intended for use inside or outside the hospital.

Inclusion Criteria:

1. Subject or legal representative has signed Informed Consent Form (ICF)

2. Age ≥ 18 years

3. BSA ≥ 1.2 m2

4. NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV

5. LVEF ≤ 25%

6. a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects
must also meet one of the following:

- On Optimal Medical Management (OMM), based on current heart failure practice
guidelines for at least 45 out of the last 60 days and are failing to respond

- Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon
pump (IABP) for at least 7 days

7. Females of child bearing age must agree to use adequate contraception

Exclusion Criteria:

1. Etiology of heart failure (HF) 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, in the judgment of
the investigator

3. Existence of ongoing mechanical circulatory support (MCS) other than IABP

4. Positive pregnancy test if of childbearing potential

5. Presence of mechanical aortic valve that will not be either converted to a
bioprosthesis or oversewn at the time of LVAD implant

6. History of any organ transplant

7. Platelet count < 100,000 x 103/L (< 100,000/ml)

8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial
issues that are likely to impair compliance with the study protocol and LVAS
management

9. History of confirmed, untreated AAA > 5 cm in diameter within 6 months of enrollment

10. Presence of an active, uncontrolled infection

11. Intolerance to anticoagulant or antiplatelet therapies or any other
peri/post-operative therapy the investigator will require based upon the patients'
health status

12. Presence of any one of the following risk factors for indications of severe end organ
dysfunction or failure:

1. An INR ≥ 2.0 not due to anticoagulation therapy

2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver
cirrhosis

3. History of severe chronic obstructive pulmonary disease (COPD) defined by
FEV1/FVC < 0.7, and FEV1 <50% predicted

4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is
unresponsive to pharmacologic intervention

5. History of stroke within 90 days prior to enrollment, or a history of
cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis

6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal
replacement therapy

7. Significant peripheral vascular disease (PVD) accompanied by rest pain or
extremity ulceration

13. Patient has moderate to severe aortic insufficiency without plans for correction
during pump implant

14. Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available) ;
pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available)

15. Planned Bi-VAD support prior to enrollment

16. Patient has known hypo or hyper coagulable states such as disseminated intravascular
coagulation and heparin induced thrombocytopenia

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

18. Any condition other than HF that could limit survival to less than 24 months