MOMENTUM 3 Continued Access Protocol

Inclusion Criteria

• Subject or legal representative has signed Informed Consent Form (ICF)
• Age ≥ 18 years
• BSA ≥ 1.2 m2
• NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
• LVEF ≤ 25%
• a) Inotrope dependent OR b) CI 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/post-operative therapy that the investigator will require based upon the patients' health status
• Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• An INR ≥ 2.0 not due to anticoagulation therapy
• Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
• History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC 80%) uncorrected carotid artery stenosis
• Serum Creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
• Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
• 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)
• Planned Bi-VAD support prior to enrollment
• Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
• Participation in any other clinical investigation that is likely to confound study results or affect the study
• Any condition other than HF that could limit survival to less than 24 months
• Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)