Advanced Refractory Left Ventricular Heart FailureMOMENTUM 3 CAPNCT02892955
MOMENTUM 3 Continued Access Protocol
A study testing HeartMate 3 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 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. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,685 participants
- Where
- 69 sitesUnited States
- Study dates
- Aug 2016to Mar 2021
- 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 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
Show all 26Show 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 Abdominal Aortic Aneurysm (AAA) > 5 cm in diameter within 6 months of enrollment
- Presence of an active, uncontrolled infection
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status
- Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
- An INR ≥ 2.0 not due to anticoagulation therapy
- Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
- History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted
- Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
- History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid artery stenosis
- Serum Creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
- Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
- Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
- Pre albumin < 150 mg/L (15mg/dL) or Albumin < 30g/L (3 g/dL) (if only one available); pre albumin < 150 mg/L (15mg/dL) and Albumin < 30g/L (3 g/dL) (if both available)
- Planned Bi-VAD support prior to enrollment
- Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
- Participation in any other clinical investigation that is likely to confound study results or affect the study
- Any condition other than HF that could limit survival to less than 24 months
- Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)
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 Medical Center
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: 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.
Read the 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.
- Being tested
- HeartMate 3 LVAS
- Keywords
- Heart Failure, LVAS, 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HeartMate 3 LVAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Survival at 24 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
Measured: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
Secondary outcomes (7)
Pump Replacement
Frequency of HeartMate 3 pump replacement at 24 months.
Measured: As they occur up to 24 months or to outcome, whichever occurs first
Six Minute Walk Test (6MWT)
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, 6 months and 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, 6 months and 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, 6 months and 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, 6 months and 24 months
Rehospitalizations
Rate of all cause rehospitalization
Measured: From initial discharge to 2 years post-implant
Adverse Event Rates
Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
Measured: 2 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 posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2020
- Study completionMar 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,685 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marie-Elena Brett, Study director, Abbott Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892955
- Sponsor's protocol ID
- MOMENTUM 3 CAP
- Acronym
- MOMENTUM 3 CAP
- Status last verified
- Jun 2022
- First submitted
- 24 Aug 2016
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26670056Uriel 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.
PubMed 26670057Schmitto 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.
PubMed 25920932Netuka 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.
PubMed 27435529Bourque 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.
PubMed 27195742Hanke 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.
PubMed 27160494Heatley 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.
PubMed 27044532Schulz 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.
PubMed 26944673Stansfield 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.
PubMed 27210469Takayama 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.
PubMed 27349284Mehra 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.
PubMed 33932272Uriel N, Sayer GT, Colombo PC, Yuzefpolskaya M, Richter I, Goldstein DJ, Jorde UP, Cleveland JC Jr, Mehra MR, Drakos SG, Gosev I, Gustafsson F, Henderson JD, Lee FS, Kanwar MK, Clerkin KJ. Survival Outcomes in Middle-Aged and Older Patients With Advanced Heart Failure: A Propensity-Matched Analysis of HeartMate 3 LVAD and Heart Transplant Using MOMENTUM 3 and UNOS Registry. JACC Heart Fail. 2026 May 10:103159. doi: 10.1016/j.jchf.2026.103159. Online ahead of print.
PubMed 42262301Sayer 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 41903627Uriel N, Sayer GT, Elad B, Fried JA, Raikhelkar JK, Lotan D, Goldstein DJ, Jorde UP, Cleveland JC Jr, Mehra MR, Drakos SG, Wood KL, Henderson JD, San Lee F, Kanwar MK, Clerkin KJ. Heart Replacement Therapy in Young Patients: A Comparative Analysis of HeartMate 3 LVAD and Heart Transplant Using MOMENTUM 3 and UNOS Registry. JACC Heart Fail. 2026 Apr;14(4):102948. doi: 10.1016/j.jchf.2026.102948. Epub 2026 Feb 7.
PubMed 41653179Sayer 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 39855458
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
- Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
- ClinicalTrials.gov ID
- NCT02892955
- Acronym / sponsor ID
- MOMENTUM 3 CAP / MOMENTUM 3 CAP
- Keywords
- Heart Failure, LVAS, Ventricular Dysfunction, Cardiomyopathy, Heart Disease, Cardiovascular Disease, Heart-assist devices, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,685 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 3 Mar 2022
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 continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Detailed description
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018. As a condition of approval, all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartMate 3 LVAS (HM3 LVAS) | Experimental | Device: HeartMate 3 LVASThe study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS. |
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 (26 listed)
- 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
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 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. | Device | HeartMate 3 LVAS (HM3 LVAS) |
Primary outcome
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
7 secondary outcomes
Pump Replacement
Time frame: 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
New York Heart Association (NYHA) Classification
Time frame: Baseline, 6 months and 24 months
EuroQol-5D-5L Visual Analogue Scale
Time frame: Baseline, 6 months and 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Baseline, 6 months and 24 months
Rehospitalizations
Time frame: From initial discharge to 2 years post-implant
Adverse Event Rates
Time frame: 2 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 26670056Netuka 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.
- Background: PubMed 26670057Uriel 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.
- Background: PubMed 25920932Schmitto 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.
- Background: PubMed 27435529Netuka 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.
- Background: PubMed 27195742Bourque 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.
- Background: PubMed 27160494Hanke 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.
- Background: PubMed 27044532Heatley 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.
- Background: PubMed 26944673Schulz 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.
- Background: PubMed 27210469Stansfield 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.
- Background: PubMed 27349284Takayama 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.
- Results publication: PubMed 33932272Mehra 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.
- Derived from this study: PubMed 42262301Uriel N, Sayer GT, Colombo PC, Yuzefpolskaya M, Richter I, Goldstein DJ, Jorde UP, Cleveland JC Jr, Mehra MR, Drakos SG, Gosev I, Gustafsson F, Henderson JD, Lee FS, Kanwar MK, Clerkin KJ. Survival Outcomes in Middle-Aged and Older Patients With Advanced Heart Failure: A Propensity-Matched Analysis of HeartMate 3 LVAD and Heart Transplant Using MOMENTUM 3 and UNOS Registry. JACC Heart Fail. 2026 May 10:103159. doi: 10.1016/j.jchf.2026.103159. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Marie-Elena Brett study director
Abbott Medical Devices
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 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 26 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 3 Mar 2022). 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?
Event-Free Survival (time frame: Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.). 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 NCT02892955, 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.