MOMENTUM 3 Continued Access Protocol

NCT02892955 | Completed Results DMC FDA Device

• 1 other identifier: MOMENTUM 3 CAP
• Study Type: interventional
• Target: 1,685
• Locations: 1 country
• Sites: 69

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.

Conditions

Advanced Refractory Left Ventricular Heart Failure

Keywords

Heart Failure; LVAS; Ventricular Dysfunction; Cardiomyopathy; Heart Disease; Cardiovascular Disease; Heart-assist devices; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• Event-Free Survival

  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 Outcomes (7)

• Pump Replacement

  As they occur up to 24 months or to outcome, whichever occurs first

• Six Minute Walk Test (6MWT)

  Baseline, 6 months and 24 months

• New York Heart Association (NYHA) Classification

  Baseline, 6 months and 24 months

• EuroQol-5D-5L Visual Analogue Scale

  Baseline, 6 months and 24 months

• Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

  Baseline, 6 months and 24 months

Study Arms (1)

HeartMate 3 LVAS (HM3 LVAS)

EXPERIMENTAL

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

Interventions

HeartMate 3 LVAS DEVICE

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.

HeartMate 3 LVAS (HM3 LVAS)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (69)

Baptist Health Medical Center - Little Rock

Little Rock, Arkansas, 72205, United States

Location

Cedars Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

Sutter Memorial Hospital

Sacramento, California, 95816, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Shands Hospital @ University of Florida

Gainesville, Florida, 32610, United States

Location

Florida Hospital

Orlando, Florida, 32804, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

IU Health/Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kentucky - Saha Cardiovascular Research Center

Lexington, Kentucky, 40536, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins Unversity Hospital

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 63198, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28206, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Hershey

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15323, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St. Thomas West Hospital

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Memorial Hermann Health Systems

Houston, Texas, 77030, United States

Location

Methodist Houston

Houston, Texas, 77030, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Bon Secours St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin Hospitals and Clinics

Madison, Wisconsin, 53792, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (18)

• Netuka I, Sood P, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Marasco S, Beyersdorf F, Damme L, Schmitto JD. Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study. J Am Coll Cardiol. 2015 Dec 15;66(23):2579-2589. doi: 10.1016/j.jacc.2015.09.083.

  PMID: 26670056 BACKGROUND

• Uriel N, Adatya S, Mehra MR. Evolution in Mechanical Circulatory Support: Are We at the Precipice of a Disruptive Innovation? J Am Coll Cardiol. 2015 Dec 15;66(23):2590-2593. doi: 10.1016/j.jacc.2015.10.028. No abstract available.

  PMID: 26670057 BACKGROUND

• Schmitto JD, Hanke JS, Rojas SV, Avsar M, Haverich A. First implantation in man of a new magnetically levitated left ventricular assist device (HeartMate III). J Heart Lung Transplant. 2015 Jun;34(6):858-60. doi: 10.1016/j.healun.2015.03.001. Epub 2015 Mar 7. No abstract available.

  PMID: 25920932 BACKGROUND

• Netuka I, Kvasnicka T, Kvasnicka J, Hrachovinova I, Ivak P, Marecek F, Bilkova J, Malikova I, Jancova M, Maly J, Sood P, Sundareswaran KS, Connors JM, Mehra MR. Evaluation of von Willebrand factor with a fully magnetically levitated centrifugal continuous-flow left ventricular assist device in advanced heart failure. J Heart Lung Transplant. 2016 Jul;35(7):860-7. doi: 10.1016/j.healun.2016.05.019. Epub 2016 May 31.

  PMID: 27435529 BACKGROUND

• Bourque K, Cotter C, Dague C, Harjes D, Dur O, Duhamel J, Spink K, Walsh K, Burke E. Design Rationale and Preclinical Evaluation of the HeartMate 3 Left Ventricular Assist System for Hemocompatibility. ASAIO J. 2016 Jul-Aug;62(4):375-83. doi: 10.1097/MAT.0000000000000388.

  PMID: 27195742 BACKGROUND

• Hanke JS, Haverich A, Schmitto JD. Exchange of a HeartMate II left ventricular assist device with a HeartMate 3 pump. J Heart Lung Transplant. 2016 Jul;35(7):944-6. doi: 10.1016/j.healun.2016.03.013. Epub 2016 Mar 30. No abstract available.

  PMID: 27160494 BACKGROUND

• Heatley G, Sood P, Goldstein D, Uriel N, Cleveland J, Middlebrook D, Mehra MR; MOMENTUM 3 Investigators. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol. J Heart Lung Transplant. 2016 Apr;35(4):528-36. doi: 10.1016/j.healun.2016.01.021. Epub 2016 Jan 30.

  PMID: 27044532 BACKGROUND

• Schulz A, Stepanenko A, Krabatsch T. HeartMate 3 implantation via left lateral thoracotomy with outflow graft anastomosis to the descending aorta. J Heart Lung Transplant. 2016 May;35(5):690-2. doi: 10.1016/j.healun.2016.01.004. Epub 2016 Jan 15. No abstract available.

  PMID: 26944673 BACKGROUND

• Stansfield WE, Rao V. HeartMate 3: Facing the challenge of past success. J Thorac Cardiovasc Surg. 2016 Sep;152(3):683-5. doi: 10.1016/j.jtcvs.2016.04.048. Epub 2016 Apr 22. No abstract available.

  PMID: 27210469 BACKGROUND

• Takayama H. Did you like Terminator 3 better than Terminator 2? "Rise of machines" with HeartMate 3? J Thorac Cardiovasc Surg. 2016 Sep;152(3):686-7. doi: 10.1016/j.jtcvs.2016.05.044. Epub 2016 Jun 2. No abstract available.

  PMID: 27349284 BACKGROUND

• Mehra MR, Cleveland JC Jr, Uriel N, Cowger JA, Hall S, Horstmanshof D, Naka Y, Salerno CT, Chuang J, Williams C, Goldstein DJ; MOMENTUM 3 Investigators. Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. Eur J Heart Fail. 2021 Aug;23(8):1392-1400. doi: 10.1002/ejhf.2211. Epub 2021 May 18.

  PMID: 33932272 RESULT

• Sayer G, Ahmed MM, Mehra MR, Gosev I, Vidula H, Devore AD, Horstmanshof DA, Cleveland JC Jr, Stewart GC, Slaughter MS, Mudy K, Wang A, Uriel N. Implantable Cardioverter-Defibrillators and Cardiovascular Resynchronization Therapy with Left Ventricular Assist DevicesA MOMENTUM 3 Trial Analysis. J Card Fail. 2025 Oct;31(10):1548-1557. doi: 10.1016/j.cardfail.2024.12.011. Epub 2025 Jan 22.

  PMID: 39855458 DERIVED

• Molina EJ, Ahmed MM, Sheikh FH, Cleveland JC Jr, Goldstein DJ, Uriel NY, Wang A, Revis JJ, Mehra MR. Left Ventricular Dimensions and Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device. JACC Heart Fail. 2025 May;13(5):798-811. doi: 10.1016/j.jchf.2024.09.019. Epub 2024 Dec 18.

  PMID: 39708027 DERIVED

• Ramu B, Cogswell R, Ravichandran AK, Cleveland J Jr, Mehra MR, Goldstein D, Uriel N, Dirckx N, Ahmed S, Yuzefpolskaya M. Clinical Outcomes With a Fully Magnetically Levitated Left Ventricular Assist Device Among Women and Men. JACC Heart Fail. 2023 Dec;11(12):1692-1704. doi: 10.1016/j.jchf.2023.08.020. Epub 2023 Oct 11.

  PMID: 37831046 DERIVED

• Mehra MR, Nayak A, Morris AA, Lanfear DE, Nemeh H, Desai S, Bansal A, Guerrero-Miranda C, Hall S, Cleveland JC Jr, Goldstein DJ, Uriel N, Chen L, Bailey S, Anyanwu A, Heatley G, Chuang J, Estep JD. Prediction of Survival After Implantation of a Fully Magnetically Levitated Left Ventricular Assist Device. JACC Heart Fail. 2022 Dec;10(12):948-959. doi: 10.1016/j.jchf.2022.08.002. Epub 2022 Oct 12.

  PMID: 36456068 DERIVED

• Uriel N, Milano C, Agarwal R, Lee S, Cleveland J, Goldstein D, Wang A, Crandall D, Mehra MR. Incidence and clinical correlates of de-novo aortic regurgitation with a fully magnetically levitated left ventricular assist device: a MOMENTUM 3 trial portfolio analysis. Eur J Heart Fail. 2023 Feb;25(2):286-294. doi: 10.1002/ejhf.2746. Epub 2022 Nov 29.

  PMID: 36404406 DERIVED

• Vidula H, Takeda K, Estep JD, Silvestry SC, Milano C, Cleveland JC Jr, Goldstein DJ, Uriel N, Kormos RL, Dirckx N, Mehra MR. Hospitalization Patterns and Impact of a Magnetically-Levitated Left Ventricular Assist Device in the MOMENTUM 3 Trial. JACC Heart Fail. 2022 Jul;10(7):470-481. doi: 10.1016/j.jchf.2022.03.007. Epub 2022 Jun 8.

  PMID: 35772857 DERIVED

• Sheikh FH, Ravichandran AK, Goldstein DJ, Agarwal R, Ransom J, Bansal A, Kim G, Cleveland JC, Uriel N, Sheridan BC, Chomsky D, Patel SR, Dirckx N, Franke A, Mehra MR. Impact of Race on Clinical Outcomes After Implantation With a Fully Magnetically Levitated Left Ventricular Assist Device: An Analysis From the MOMENTUM 3 Trial. Circ Heart Fail. 2021 Oct;14(10):e008360. doi: 10.1161/CIRCHEARTFAILURE.120.008360. Epub 2021 Sep 16.

  PMID: 34525837 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This is a single arm study.

Results Point of Contact

• Title: Joyce Chuang
• Organization: Abbott

joyce.chuang@abbott.com

9253535817

Study Officials

• Marie-Elena Brett

  Abbott Medical Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 8, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 27, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (69)