MOMENTUM 3 IDE Clinical Study Protocol (HM3™)
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, Left Ventricular Assist Device, Ventricular Dysfunction, Cardiomyopathy, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
Eligibility Criteria
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 < 2.2 L/min/m2, while not on inotropes and subjects 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
- 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:
- 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
- Existence of ongoing mechanical circulatory support (MCS) other than IABP
- Positive pregnancy test if of childbearing potential
- Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn 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 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 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 < 0.7, and 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%) uncorrected carotid 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
Sites / Locations
- Baptist Health Medical Center - Little Rock
- Cedars Sinai Medical Center
- University of California, San Diego
- Sutter Memorial Hospital
- Sharp Memorial Hospital
- California Pacific Medical Center
- Stanford University
- University of Colorado Hospital
- Yale New Haven Hospital
- MedStar Washington Hospital Center
- Shands Hospital @ University of Florida
- Florida Hospital
- Tampa General Hospital
- Piedmont Heart Institute
- Emory University Hospital
- Northwestern Memorial Hospital
- University of Chicago Medical Center
- Advocate Christ Medical Center
- IU Health/Methodist Hospital
- St. Vincent Hospital
- University of Iowa Hospitals and Clinics
- University of Kentucky - Saha Cardiovascular Research Center
- Jewish Hospital
- Ochsner Medical Center
- Johns Hopkins Unversity Hospital
- Massachusetts General Hospital
- Brigham & Women's Hospital
- University of Michigan
- Henry Ford Hospital
- Spectrum Health Butterworth Hospital
- Abbott Northwestern Hospital
- University of Minnesota Medical Center, Fairview
- Mayo Clinic Rochester
- Barnes Jewish Hospital
- University of Nebraska Medical Center
- Newark Beth Israel Medical Center
- Montefiore Medical Center
- Mt. Sinai Medical Center
- Columbia University Medical Center
- University of Rochester Medical Center
- University of North Carolina at Chapel Hill
- Carolinas Medical Center
- Duke University
- University Hospitals of Cleveland
- Cleveland Clinic Foundation
- Ohio State University Medical Center
- INTEGRIS Baptist Medical Center
- Oregon Health and Science University
- Hershey
- Hospital of the University of Pennsylvania
- Thomas Jefferson University Hospital
- Allegheny General Hospital
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- St. Thomas West Hospital
- Vanderbilt University Medical Center
- Baylor Research Institute
- Memorial Hermann Health Systems
- Methodist Houston
- Texas Heart Institute
- University of Utah Hospital and Clinics
- University of Virginia Medical Center
- Inova Fairfax Hospital
- Sentara Norfolk General Hospital
- Bon Secours St. Mary's Hospital
- Virginia Commonwealth University
- University of Washington Medical Center
- University of Wisconsin Hospitals and Clinics
- St. Luke's Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
HeartMate 3 LVAS (HM3 LVAS)
HeartMate II LVAS
Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.