MOMENTUM 3 IDE Clinical Study Protocol

NCT02224755 | Completed Results DMC

• 1 other identifier: TC03062014
• Study Type: interventional
• Target: 1,028
• Locations: 1 country
• Sites: 69

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.

Conditions

Advanced Refractory Left Ventricular Heart Failure

Keywords

Heart Failure; Left Ventricular Assist Device; Ventricular Dysfunction; Cardiomyopathy; Heart Disease; Cardiovascular Disease; Heart-assist devices; Thoratec Corporation

Outcome Measures

Primary Outcomes (2)

• Short Term Primary End Point

  Survival at 6 months free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device

  The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.

• Long Term Primary End Point

  Survival at 2 years free of disabling stroke (Modified Rankin Score \> 3) or reoperation to replace or remove a malfunctioning device

  The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.

Secondary Outcomes (8)

• Powered Secondary End Point: Pump Replacement at Two Years

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

• EuroQoL 5D-5L (EQ-5D-5L) Total Score

  Baseline to 24 months

• EuroQol-5D-5L Visual Analogue Scale

  Baseline to 24 months

• Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score

  Baseline to 24 months

• Six Minute Walk Test

  Baseline to 24 months

Study Arms (2)

HeartMate 3 LVAS (HM3 LVAS)

EXPERIMENTAL

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.

Device: HeartMate 3 LVAS

HeartMate II LVAS

ACTIVE COMPARATOR

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.

Device: HeartMate II LVAS

Interventions

HeartMate 3 LVAS DEVICE

Implantation of HeartMate 3 LVAD to evaluate 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 3 LVAS (HM3 LVAS)

HeartMate II LVAS DEVICE

Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure

HeartMate II 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 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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Thoratec Corporation: collaborator

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

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 (20)

• Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.

  PMID: 27959709 BACKGROUND

• 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

• Shah P, Sayer G, Sinha SS, Kanwar MK, Cowger JA, Pagani FD, Nayak A, Mehra MR, Cleveland JC Jr, Psotka MA, Singh R, Desai SS, Lu Q, Hu Y, Connolly A, Kormos RL, Uriel N. Dynamic Risk Estimation of Adverse Events in Ambulatory LVAD Patients: A MOMENTUM 3 Analysis. JACC Heart Fail. 2024 Nov;12(11):1898-1912. doi: 10.1016/j.jchf.2024.05.018. Epub 2024 Jul 24.

  PMID: 39066758 DERIVED

• Nayak A, Hall SA, Uriel N, Goldstein DJ, Cleveland JC Jr, Cowger JA, Salerno CT, Naka Y, Horstmanshof D, Crandall D, Wang A, Mehra MR. Predictors of 5-Year Mortality in Patients Managed With a Magnetically Levitated Left Ventricular Assist Device. J Am Coll Cardiol. 2023 Aug 29;82(9):771-781. doi: 10.1016/j.jacc.2023.05.066.

  PMID: 37612008 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

• Mehra MR, Goldstein DJ, Cleveland JC, Cowger JA, Hall S, Salerno CT, Naka Y, Horstmanshof D, Chuang J, Wang A, Uriel N. Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial. JAMA. 2022 Sep 27;328(12):1233-1242. doi: 10.1001/jama.2022.16197.

  PMID: 36074476 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

• Lundgren SW, Florescu DF, Zolty R. Reactivation of Cytomegalovirus Following Left Ventricular Assist Device Implantation: A Case-Control Study. ASAIO J. 2021 Apr 1;67(4):405-410. doi: 10.1097/MAT.0000000000001236.

  PMID: 32740125 DERIVED

• Saeed O, Colombo PC, Mehra MR, Uriel N, Goldstein DJ, Cleveland J, Connors JM, Najjar SS, Mokadam NA, Bansal A, Crandall DL, Sood P, Jorde UP. Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study. J Heart Lung Transplant. 2020 Jun;39(6):518-525. doi: 10.1016/j.healun.2020.03.001. Epub 2020 Mar 20.

  PMID: 32340871 DERIVED

• Patel CB, Blue L, Cagliostro B, Bailey SH, Entwistle JW, John R, Thohan V, Cleveland JC Jr, Goldstein DJ, Uriel N, Su X, Somo SI, Sood P, Mehra MR. Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial. J Heart Lung Transplant. 2020 Aug;39(8):774-781. doi: 10.1016/j.healun.2020.03.002. Epub 2020 Mar 20.

  PMID: 32276809 DERIVED

• Goldstein DJ, Naka Y, Horstmanshof D, Ravichandran AK, Schroder J, Ransom J, Itoh A, Uriel N, Cleveland JC Jr, Raval NY, Cogswell R, Suarez EE, Lowes BD, Kim G, Bonde P, Sheikh FH, Sood P, Farrar DJ, Mehra MR. Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial. JAMA Cardiol. 2020 Apr 1;5(4):411-419. doi: 10.1001/jamacardio.2019.5323.

  PMID: 31939996 DERIVED

• Mehra MR, Uriel N, Naka Y, Cleveland JC Jr, Yuzefpolskaya M, Salerno CT, Walsh MN, Milano CA, Patel CB, Hutchins SW, Ransom J, Ewald GA, Itoh A, Raval NY, Silvestry SC, Cogswell R, John R, Bhimaraj A, Bruckner BA, Lowes BD, Um JY, Jeevanandam V, Sayer G, Mangi AA, Molina EJ, Sheikh F, Aaronson K, Pagani FD, Cotts WG, Tatooles AJ, Babu A, Chomsky D, Katz JN, Tessmann PB, Dean D, Krishnamoorthy A, Chuang J, Topuria I, Sood P, Goldstein DJ; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Left Ventricular Assist Device - Final Report. N Engl J Med. 2019 Apr 25;380(17):1618-1627. doi: 10.1056/NEJMoa1900486. Epub 2019 Mar 17.

  PMID: 30883052 DERIVED

• Colombo PC, Mehra MR, Goldstein DJ, Estep JD, Salerno C, Jorde UP, Cowger JA, Cleveland JC Jr, Uriel N, Sayer G, Skipper ER, Downey FX, Ono M, Hooker R Jr, Anyanwu AC, Givertz MM, Mahr C, Topuria I, Somo SI, Crandall DL, Horstmanshof DA. Comprehensive Analysis of Stroke in the Long-Term Cohort of the MOMENTUM 3 Study. Circulation. 2019 Jan 8;139(2):155-168. doi: 10.1161/CIRCULATIONAHA.118.037231.

  PMID: 30586698 DERIVED

• Mehra MR, Salerno C, Naka Y, Uriel N, Cleveland JC, Horstmanshof D, Goldstein DJ; MOMENTUM 3 Investigators. A tale of the twist in the outflow graft: An analysis from the MOMENTUM 3 trial. J Heart Lung Transplant. 2018 Nov;37(11):1281-1284. doi: 10.1016/j.healun.2018.08.011. Epub 2018 Aug 24. No abstract available.

  PMID: 30245150 DERIVED

• Mehra MR, Salerno C, Cleveland JC, Pinney S, Yuzefpolskaya M, Milano CA, Itoh A, Goldstein DJ, Uriel N, Gulati S, Pagani FD, John R, Adamson R, Bogaev R, Thohan V, Chuang J, Sood P, Goates S, Silvestry SC. Healthcare Resource Use and Cost Implications in the MOMENTUM 3 Long-Term Outcome Study. Circulation. 2018 Oct 30;138(18):1923-1934. doi: 10.1161/CIRCULATIONAHA.118.035722.

  PMID: 29807933 DERIVED

• Mehra MR, Goldstein DJ, Uriel N, Cleveland JC Jr, Yuzefpolskaya M, Salerno C, Walsh MN, Milano CA, Patel CB, Ewald GA, Itoh A, Dean D, Krishnamoorthy A, Cotts WG, Tatooles AJ, Jorde UP, Bruckner BA, Estep JD, Jeevanandam V, Sayer G, Horstmanshof D, Long JW, Gulati S, Skipper ER, O'Connell JB, Heatley G, Sood P, Naka Y; MOMENTUM 3 Investigators. Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure. N Engl J Med. 2018 Apr 12;378(15):1386-1395. doi: 10.1056/NEJMoa1800866. Epub 2018 Mar 11.

  PMID: 29526139 DERIVED

• Goldstein DJ, Mehra MR, Naka Y, Salerno C, Uriel N, Dean D, Itoh A, Pagani FD, Skipper ER, Bhat G, Raval N, Bruckner BA, Estep JD, Cogswell R, Milano C, Fendelander L, O'Connell JB, Cleveland J; MOMENTUM 3 Investigators. Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial. J Heart Lung Transplant. 2018 Jan;37(1):7-14. doi: 10.1016/j.healun.2017.11.001. Epub 2017 Nov 3.

  PMID: 29154131 DERIVED

• Cowger JA, Naka Y, Aaronson KD, Horstmanshof D, Gulati S, Rinde-Hoffman D, Pinney S, Adatya S, Farrar DJ, Jorde UP; MOMENTUM 3 Investigators. Quality of life and functional capacity outcomes in the MOMENTUM 3 trial at 6 months: A call for new metrics for left ventricular assist device patients. J Heart Lung Transplant. 2018 Jan;37(1):15-24. doi: 10.1016/j.healun.2017.10.019. Epub 2017 Oct 24.

  PMID: 29153637 DERIVED

• Uriel N, Colombo PC, Cleveland JC, Long JW, Salerno C, Goldstein DJ, Patel CB, Ewald GA, Tatooles AJ, Silvestry SC, John R, Caldeira C, Jeevanandam V, Boyle AJ, Sundareswaran KS, Sood P, Mehra MR. Hemocompatibility-Related Outcomes in the MOMENTUM 3 Trial at 6 Months: A Randomized Controlled Study of a Fully Magnetically Levitated Pump in Advanced Heart Failure. Circulation. 2017 May 23;135(21):2003-2012. doi: 10.1161/CIRCULATIONAHA.117.028303. Epub 2017 Apr 6.

  PMID: 28385948 DERIVED

MeSH Terms

Conditions

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

Limitations and Caveats

This was a non-blinded study

Results Point of Contact

• Title: Joyce Chuang/Principal scientist
• Organization: Abbott

joyce.chuang@abbott.com

925-353-5817

Study Officials

• Daniel Crandall, PhD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: September 2, 2014
• Primary Completion: September 28, 2018
• Study Completion: March 26, 2019
• Last Updated: June 27, 2022
• Results First Posted: November 20, 2019

Record last verified: 2022-06

Locations

US (69)