MOMENTUM 3 Continued Access Protocol (MOMENTUM 3 CAP)

June 23, 2022 updated by: Abbott Medical Devices

Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1685

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Medical Center - Little Rock
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars Sinai Medical Center
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • Sacramento, California, United States, 95816
        • Sutter Memorial Hospital
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital @ University of Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital
      • Indianapolis, Indiana, United States, 46202
        • IU Health/Methodist Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky - Saha Cardiovascular Research Center
      • Louisville, Kentucky, United States, 40202
        • Jewish Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Unversity Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02214
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Butterworth Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center, Fairview
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 63198
        • University of Nebraska Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mt. Sinai Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina At Chapel Hill
      • Charlotte, North Carolina, United States, 28206
        • Carolinas Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Hershey
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15323
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • St. Thomas West Hospital
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
      • Houston, Texas, United States, 77030
        • Texas Heart Institute
      • Houston, Texas, United States, 77030
        • Memorial Hermann Health Systems
      • Houston, Texas, United States, 77030
        • Methodist Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital and Clinics
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary's Hospital
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospitals and Clinics
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject or legal representative has signed Informed Consent Form (ICF)
  2. Age ≥ 18 years
  3. BSA ≥ 1.2 m2
  4. NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
  5. LVEF ≤ 25%

  6. 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,
  7. Females of child bearing age must agree to use adequate contraception

Exclusion Criteria:

  1. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
  2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
  3. Existence of ongoing mechanical circulatory support (MCS) other than IABP
  4. Positive pregnancy test if of childbearing potential
  5. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant
  6. History of any organ transplant
  7. Platelet count < 100,000 x 103/L (< 100,000/ml)
  8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
  9. History of confirmed, untreated Abdominal Aortic Aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
  10. Presence of an active, uncontrolled infection
  11. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status

  12. 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
  13. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
  14. 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)
  15. Planned Bi-VAD support prior to enrollment
  16. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
  17. Participation in any other clinical investigation that is likely to confound study results or affect the study
  18. Any condition other than HF that could limit survival to less than 24 months
  19. Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HeartMate 3 LVAS (HM3 LVAS)
The study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
Device: HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD 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 MOMENTUM 3 IDE Study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival
Time Frame: 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
Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Marie-Elena Brett, Abbott Medical Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOMENTUM 3 CAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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