MOMENTUM 3 IDE Clinical Study Protocol

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