HeartMate 3™ CE Mark Clinical Investigation Plan

Inclusion criteria

• Patient or legal representative has signed Informed Consent Form (ICF)
• Age ≥ 18 years
• BSA ≥ 1.2 m2
• NYHA IIIB or IV OR ACC/AHA Stage D
• LVEF ≤ 25%
• CI ≤ 2.2 L/min/m2, while not on inotropes
• Patients 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,

OR

• In NYHA class IIIB or IV heart failure for at least 14 days AND dependent on intraaortic balloon pump (IABP) for at least 7 days,

OR

• Inotrope dependent/unable to wean from inotropes

OR

• Listed for Transplant
• Females of child bearing age must agree to use adequate contraception

Exclusion criteria

• Etiology of 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
• Existence of ongoing mechanical circulatory support (MCS) other than IABP
• Positive pregnancy test if of childbearing potential
• Lactating mothers
• Presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of LVAD implant
• History of any organ transplant
• 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
• 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 patients' health status
• Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:

• An INR ≥ 2.5 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 < 0.7, or FEV1 <50% predicted
• Fixed pulmonary hypertension with a 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%) carotid artery stenosis
• Serum creatinine ≥221umol/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, or Albumin < 30g/L (3 g/dL)
• 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