Advanced Refractory Left Ventricular Heart FailureHM3™NCT02224755
MOMENTUM 3 IDE Clinical Study Protocol
A study testing HeartMate 3 LVAS and HeartMate II LVAS in people with Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 69 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advanced Refractory Left Ventricular Heart Failure
- What is being tested?
- HeartMate 3 LVAS and HeartMate II LVAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,028 participants
- Where
- 69 sitesUnited States
- Study dates
- 2 Sep 2014to 26 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
- 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 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
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30309
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado Hospital
Aurora, Colorado, 80045
Johns Hopkins Unversity Hospital
Baltimore, Maryland, 21287
Cedars Sinai Medical Center
Beverly Hills, California, 90211
Massachusetts General Hospital
Boston, Massachusetts, 02214
Brigham & Women's Hospital
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Carolinas Medical Center
Charlotte, North Carolina, 28206
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University Medical Center
Columbus, Ohio, 43210
Baylor Research Institute
Dallas, Texas, 75246
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Shands Hospital @ University of Florida
Gainesville, Florida, 32610
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, 49503
Hershey
Hershey, Pennsylvania, 17033
Memorial Hermann Health Systems
Houston, Texas, 77030
Methodist Houston
Houston, Texas, 77030
Texas Heart Institute
Houston, Texas, 77030
IU Health/Methodist Hospital
Indianapolis, Indiana, 46202
St. Vincent Hospital
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California, San Diego
La Jolla, California, 92037
University of Kentucky - Saha Cardiovascular Research Center
Lexington, Kentucky, 40536
Baptist Health Medical Center - Little Rock
Little Rock, Arkansas, 72205
Jewish Hospital
Louisville, Kentucky, 40202
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53792
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
St. Thomas West Hospital
Nashville, Tennessee, 37205
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale New Haven Hospital
New Haven, Connecticut, 06510
Ochsner Medical Center
New Orleans, Louisiana, 70121
Mt. Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 63198
Florida Hospital
Orlando, Florida, 32804
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15323
Oregon Health and Science University
Portland, Oregon, 97239
Bon Secours St. Mary's Hospital
Richmond, Virginia, 23226
Virginia Commonwealth University
Richmond, Virginia, 23298
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Rochester Medical Center
Rochester, New York, 14642
Sutter Memorial Hospital
Sacramento, California, 95816
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Sharp Memorial Hospital
San Diego, California, 92123
California Pacific Medical Center
San Francisco, California, 94115
University of Washington Medical Center
Seattle, Washington, 98195
Barnes Jewish Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Tampa General Hospital
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
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.
Read the 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.
- Being tested
- HeartMate 3 LVAS, HeartMate II LVAS
- Keywords
- Heart Failure, Left Ventricular Assist Device, Ventricular Dysfunction, Cardiomyopathy, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartMate 3 LVASDevice
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 II LVASDevice
Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: HeartMate II LVAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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.
Measured: As they occur up to 24 months or to Outcome, whichever occurs first
EuroQoL 5D-5L (EQ-5D-5L) Total Score
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.
Measured: Baseline to 24 months
EuroQol-5D-5L Visual Analogue Scale
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.
Measured: Baseline to 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
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.
Measured: Baseline to 24 months
Six Minute Walk Test
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.
Measured: Baseline to 24 months
New York Heart Association (NYHA) Classification
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.
Measured: Baseline to 24 months
Rehospitalizations
Rate of all cause rehospitalization
Measured: From initial discharge to two years post-implant
Adverse Event Rates
Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Measured: Two years post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study start2 Sep 2014
- Primary completion28 Sep 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Advanced Refractory Left Ventricular Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Responsible party
- Sponsor
- Investigators
- Daniel Crandall, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224755
- Sponsor's protocol ID
- TC03062014
- Acronym
- HM3™
- Status last verified
- Jun 2022
- First submitted
- 21 Aug 2014
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27959709Sayer G, Elad B, Goldstein D, Cleveland J, Kanwar M, Gosev I, Jorde U, Wang A, O'Connell K, Gazzola C, Bell K, Takeda K, Yuzefpolskaya M, Mehra MR, Uriel N; MOMENTUM 3 investigators. Early right ventricular failure following HeartMate 3 left ventricular assist device implantation: Risk factors and outcomes. J Heart Lung Transplant. 2026 Jul;45(7):1081-1090. doi: 10.1016/j.healun.2026.03.025. Epub 2026 Mar 26.
PubMed 41903627Sayer 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.
PubMed 39855458Shah 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.
PubMed 39066758Nayak 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.
PubMed 37612008Mehra 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.
PubMed 36456068Uriel 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.
PubMed 36404406Mehra 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.
PubMed 36074476Sheikh 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.
PubMed 34525837Lundgren 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.
PubMed 32740125Saeed 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.
PubMed 32340871Patel 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.
PubMed 32276809Goldstein 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.
PubMed 31939996Mehra 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.
PubMed 30883052Colombo 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.
PubMed 30586698
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT02224755
- Acronym / sponsor ID
- HM3™ / TC03062014
- Keywords
- Heart Failure, Left Ventricular Assist Device, Ventricular Dysfunction, Cardiomyopathy, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- Thoratec Corporation
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Posted 20 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Experimental | Device: HeartMate 3 LVASEvaluation 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 | Active comparator | Device: HeartMate II LVASEvaluation 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartMate 3 LVASImplantation 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 | Device | HeartMate 3 LVAS (HM3 LVAS) |
| HeartMate II LVASImplantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure | Device | HeartMate II LVAS |
Primary outcome
Short Term Primary End Point
Time frame: 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
Time frame: 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
8 secondary outcomes
Powered Secondary End Point: Pump Replacement at Two Years
Time frame: As they occur up to 24 months or to Outcome, whichever occurs first
EuroQoL 5D-5L (EQ-5D-5L) Total Score
Time frame: Baseline to 24 months
EuroQol-5D-5L Visual Analogue Scale
Time frame: Baseline to 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Baseline to 24 months
Six Minute Walk Test
Time frame: Baseline to 24 months
New York Heart Association (NYHA) Classification
Time frame: Baseline to 24 months
Rehospitalizations
Time frame: From initial discharge to two years post-implant
Adverse Event Rates
Time frame: Two years post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27959709Mehra 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.
- Derived from this study: PubMed 41903627Sayer G, Elad B, Goldstein D, Cleveland J, Kanwar M, Gosev I, Jorde U, Wang A, O'Connell K, Gazzola C, Bell K, Takeda K, Yuzefpolskaya M, Mehra MR, Uriel N; MOMENTUM 3 investigators. Early right ventricular failure following HeartMate 3 left ventricular assist device implantation: Risk factors and outcomes. J Heart Lung Transplant. 2026 Jul;45(7):1081-1090. doi: 10.1016/j.healun.2026.03.025. Epub 2026 Mar 26.
- Derived from this study: PubMed 39855458Sayer 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.
- Derived from this study: PubMed 39066758Shah 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.
- Derived from this study: PubMed 37612008Nayak 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.
- Derived from this study: PubMed 36456068Mehra 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.
- Derived from this study: PubMed 36404406Uriel 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.
- Derived from this study: PubMed 36074476Mehra 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.
- Derived from this study: PubMed 34525837Sheikh 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.
- Derived from this study: PubMed 32740125Lundgren 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.
- Derived from this study: PubMed 32340871Saeed 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.
- Derived from this study: PubMed 32276809Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Crandall, PhD study director
Abbott
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartMate 3 LVAS and HeartMate II LVAS in people with Advanced Refractory Left Ventricular Heart Failure, run by Abbott Medical Devices at 69 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Term Primary End Point (time frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02224755, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.