MOMENTUM 3 IDE Clinical Study Protocol

Not Applicable

Completed

Conditions: Advanced Refractory Left Ventricular Heart Failure

Interventions: Device: HeartMate 3 LVAS
Device: HeartMate II LVAS

Registration Number: NCT02224755

Lead Sponsor: Abbott Medical Devices

Brief Summary: The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Detailed Description: The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory left ventricular heart failure; either for short term support, such as a bridge to cardiac transplantation (BTT) or myocardial recovery, or as long term support, such as destination therapy (DT). The HM3 is intended for use inside or outside the hospital.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1028

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:
1. An INR ≥ 2.0 not due to anticoagulation therapy
2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis
6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
7. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeartMate 3 LVAS (HM3 LVAS)	HeartMate 3 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.
HeartMate II 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.

Primary Outcome Measures

Name	Time	Method
Short Term Primary End Point	The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.	Survival at 6 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device
Long Term Primary End Point	The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.	Survival at 2 years free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device

Secondary Outcome Measures

Name	Time	Method
Adverse Event Rates	Two years post-implant	Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Powered Secondary End Point: Pump Replacement at Two Years	As they occur up to 24 months or to Outcome, whichever occurs first	In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.
EuroQoL 5D-5L (EQ-5D-5L) Total Score	Baseline to 24 months	Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
EuroQol-5D-5L Visual Analogue Scale	Baseline to 24 months	Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.
Six Minute Walk Test	Baseline to 24 months	Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
New York Heart Association (NYHA) Classification	Baseline to 24 months	Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.
Rehospitalizations	From initial discharge to two years post-implant	Rate of all cause rehospitalization
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Baseline to 24 months	Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.

Trial Locations

Locations (69): University of Chicago Medical Center
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Chicago, Illinois, United States
Ohio State University Medical Center
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Columbus, Ohio, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Baptist Health Medical Center - Little Rock
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Little Rock, Arkansas, United States
University of California, San Diego
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La Jolla, California, United States
Advocate Christ Medical Center
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Oak Lawn, Illinois, United States
Mt. Sinai Medical Center
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New York, New York, United States
Stanford University
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Stanford, California, United States
Columbia University Medical Center
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New York, New York, United States
Newark Beth Israel Medical Center
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Newark, New Jersey, United States
Carolinas Medical Center
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Charlotte, North Carolina, United States
Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, United States
Sentara Norfolk General Hospital
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Norfolk, Virginia, United States
Johns Hopkins Unversity Hospital
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Baltimore, Maryland, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States
Cleveland Clinic Foundation
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Cleveland, Ohio, United States
Sharp Memorial Hospital
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San Diego, California, United States
IU Health/Methodist Hospital
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Indianapolis, Indiana, United States
University of Minnesota Medical Center, Fairview
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Minneapolis, Minnesota, United States
University of Utah Hospital and Clinics
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Salt Lake City, Utah, United States
California Pacific Medical Center
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San Francisco, California, United States
Emory University Hospital
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Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics
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Iowa City, Iowa, United States
Brigham & Women's Hospital
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Boston, Massachusetts, United States
Spectrum Health Butterworth Hospital
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Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
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Minneapolis, Minnesota, United States
Duke University
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Durham, North Carolina, United States
Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States
St. Thomas West Hospital
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Nashville, Tennessee, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
Baylor Research Institute
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Dallas, Texas, United States
Memorial Hermann Health Systems
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Houston, Texas, United States
Texas Heart Institute
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Houston, Texas, United States
University of Washington Medical Center
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Seattle, Washington, United States
University of Rochester Medical Center
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Rochester, New York, United States
Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States
University Hospitals of Cleveland
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Cleveland, Ohio, United States
University of Virginia Medical Center
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Charlottesville, Virginia, United States
Methodist Houston
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Houston, Texas, United States
Inova Fairfax Hospital
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Falls Church, Virginia, United States
Bon Secours St. Mary's Hospital
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Richmond, Virginia, United States
Virginia Commonwealth University
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Richmond, Virginia, United States
University of Wisconsin Hospitals and Clinics
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Madison, Wisconsin, United States
Hershey
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Hershey, Pennsylvania, United States
Shands Hospital @ University of Florida
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Gainesville, Florida, United States
MedStar Washington Hospital Center
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Washington, District of Columbia, United States
Piedmont Heart Institute
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Atlanta, Georgia, United States
University of Kentucky - Saha Cardiovascular Research Center
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Lexington, Kentucky, United States
Ochsner Medical Center
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New Orleans, Louisiana, United States
St. Vincent Hospital
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Indianapolis, Indiana, United States
Barnes Jewish Hospital
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Saint Louis, Missouri, United States
University of Michigan
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Ann Arbor, Michigan, United States
Henry Ford Hospital
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Detroit, Michigan, United States
Mayo Clinic Rochester
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Rochester, Minnesota, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
Sutter Memorial Hospital
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Sacramento, California, United States
Yale New Haven Hospital
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New Haven, Connecticut, United States
Florida Hospital
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Orlando, Florida, United States
Tampa General Hospital
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Tampa, Florida, United States
INTEGRIS Baptist Medical Center
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Oklahoma City, Oklahoma, United States
Jewish Hospital
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Louisville, Kentucky, United States
University of Nebraska Medical Center
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Omaha, Nebraska, United States
University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, United States
Oregon Health and Science University
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Portland, Oregon, United States
St. Luke's Medical Center
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Milwaukee, Wisconsin, United States
University of Colorado Hospital
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Aurora, Colorado, United States
Cedars Sinai Medical Center
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Beverly Hills, California, United States
Northwestern Memorial Hospital
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Chicago, Illinois, United States
Montefiore Medical Center
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Bronx, New York, United States