HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark)
Advanced Refractory Left Ventricular Heart Failure
About this trial
This is an interventional treatment trial for Advanced Refractory Left Ventricular Heart Failure focused on measuring Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
Eligibility Criteria
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
Sites / Locations
- The Alfred Hospital
- AKH Medical University of Vienna
- Toronto General Hospital
- Institute for Clinical and Experimental Medicine (IKEM)
- Herz- und Diabeteszentrum NRW Thorax- und Kardiovaskularchirurgie Clinic
- Deutsches Herzzentrum Berlin
- Universitats-Herzzentrum Freiburg
- Medizinische Hochschule Hannover
- Herzentrum Leipzig GmbH
- National Research Center for Cardiac Surgery
Arms of the Study
Arm 1
Experimental
HeartMate 3
Left Ventricular Assist System (LVAS) to be used on Subjects with advanced refractory left ventricular heart failure