Study Results
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View full resultsBasic Information
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COMPLETED
NA
1685 participants
INTERVENTIONAL
2016-08-31
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HeartMate 3 LVAS (HM3 LVAS)
The study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.
Interventions
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HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the MOMENTUM 3 IDE Study.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years
3. BSA ≥ 1.2 m2
4. NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
5. LVEF ≤ 25%
6. a) Inotrope dependent OR b) CI \< 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following:
* On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond
* Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days,
7. Females of child bearing age must agree to use adequate contraception
Exclusion Criteria
2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
3. Existence of ongoing mechanical circulatory support (MCS) other than IABP
4. Positive pregnancy test if of childbearing potential
5. Presence of mechanical aortic cardiac valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant
6. History of any organ transplant
7. Platelet count \< 100,000 x 103/L (\< 100,000/ml)
8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management
9. History of confirmed, untreated Abdominal Aortic Aneurysm (AAA) \> 5 cm in diameter within 6 months of enrollment
10. Presence of an active, uncontrolled infection
11. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status
12. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
* An INR ≥ 2.0 not due to anticoagulation therapy
* Total bilirubin \> 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
* History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, and FEV1 \<50% predicted
* Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention
* History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid artery stenosis
* Serum Creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy
* Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration
13. Patient has moderate to severe aortic insufficiency without plans for correction during pump implant
14. Pre albumin \< 150 mg/L (15mg/dL) or Albumin \< 30g/L (3 g/dL) (if only one available); pre albumin \< 150 mg/L (15mg/dL) and Albumin \< 30g/L (3 g/dL) (if both available)
15. Planned Bi-VAD support prior to enrollment
16. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
17. Participation in any other clinical investigation that is likely to confound study results or affect the study
18. Any condition other than HF that could limit survival to less than 24 months
19. Patients actively listed for heart transplant (this exclusion applies only after commercial approval of the HM3 for short-term use)
18 Years
100 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Elena Brett
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Baptist Health Medical Center - Little Rock
Little Rock, Arkansas, United States
Cedars Sinai Medical Center
Beverly Hills, California, United States
University of California, San Diego
La Jolla, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Shands Hospital @ University of Florida
Gainesville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
IU Health/Methodist Hospital
Indianapolis, Indiana, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky - Saha Cardiovascular Research Center
Lexington, Kentucky, United States
Jewish Hospital
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Johns Hopkins Unversity Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health Butterworth Hospital
Grand Rapids, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mt. Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Hershey
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
St. Thomas West Hospital
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
Memorial Hermann Health Systems
Houston, Texas, United States
Methodist Houston
Houston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 Jan 22:S1071-9164(25)00012-0. doi: 10.1016/j.cardfail.2024.12.011. Online ahead of print.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MOMENTUM 3 CAP
Identifier Type: -
Identifier Source: org_study_id
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