Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS

Inclusion criteria

• Subject or Legal Representative has provided written informed consent by signing the study Informed Consent Form (ICF)
• Subject must be ≥ 18 years of age at the time of informed consent
• Subject is receiving the HM3 as their first LVAD
• Body surface area (BSA) ≥ 1.2m2
• Subject is NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
• LVEF ≤ 25%
• Subject is:

• Inotrope dependent OR
• Has CI<2.2 L/min/m2, while not on inotropes and meets one of the following criteria:

• On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond to therapy
• Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days
• Females of child bearing age must agree to use adequate contraception

Exclusion criteria

• Subject has a planned concomitant procedure at time of implant (e.g. valve repair, CABG, ASD repair, etc)
• Subject has greater than mild aortic insufficiency
• Physiologically significant (i.e. requires intervention) atrial septal defect
• Subject has severe right heart failure (RHF) (refer to Appendix 2 for guidance)
• Subject has planned Bi-VAD support prior to enrollment
• Presence of mechanical aortic valve that will not be either converted to bioprosthesis or oversewn at the time of LVAD implant
• Subject has ongoing mechanical circulatory support (MCS) at the time of LVAD surgery other than IABP
• Subject has a history of any organ transplant
• Positive pregnancy test
• Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
• Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
• Platelet count < 100,000 x 103/L (< 100,000/ml)
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
• History of confirmed, untreated AAA > 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 the investigator will require based upon the subjects' 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 μmol/L (2.5 mg/dl) or biopsy-proven liver cirrhosis
• History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
• Fixed pulmonary hypertension with most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
• History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
• Serum creatinine ≥ 221 μmol/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
• Pre-albumin < 150mg/liter (15 mg/dl) or albumin <30 g/liter (3g/dl) (if only one available); pre-albumin <150mg/liter (15 mg/dl) and albumin <30 g/liter (3 g/dl) (if both available)
• Subject 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