MOMENTUM 3 Continued Access Protocol

Not Applicable

Completed

Conditions: Advanced Refractory Left Ventricular Heart Failure

Interventions: Device: HeartMate 3 LVAS

Registration Number: NCT02892955

Lead Sponsor: Abbott Medical Devices

Brief Summary: The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.

Detailed Description: Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1685

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 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 cardiac 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 Abdominal Aortic Aneurysm (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 that 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 artery 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
Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HeartMate 3 LVAS (HM3 LVAS)	HeartMate 3 LVAS	The study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.

Primary Outcome Measures

Name	Time	Method
Event-Free Survival	Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.	Survival at 24 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device

Secondary Outcome Measures

Name	Time	Method
Six Minute Walk Test (6MWT)	Baseline, 6 months and 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.
Pump Replacement	As they occur up to 24 months or to outcome, whichever occurs first	Frequency of HeartMate 3 pump replacement at 24 months.
New York Heart Association (NYHA) Classification	Baseline, 6 months and 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.
EuroQol-5D-5L Visual Analogue Scale	Baseline, 6 months and 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.
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score	Baseline, 6 months and 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.
Adverse Event Rates	2 years post-implant	Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Rehospitalizations	From initial discharge to 2 years post-implant	Rate of all cause rehospitalization

Trial Locations

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