Advanced Refractory Left Ventricular Heart Failure Clinical Trial
— HM3™Official title:
Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol
Verified date | June 2022 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1028 |
Est. completion date | March 26, 2019 |
Est. primary completion date | September 28, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: 1. Subject or legal representative has signed Informed Consent Form (ICF) 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: 1. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy 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 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 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 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: 1. An INR = 2.0 not due to anticoagulation therapy 2. Total bilirubin > 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis 3. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, and FEV1 <50% predicted 4. Fixed pulmonary hypertension with a most recent PVR = 8 Wood units that is unresponsive to pharmacologic intervention 5. History of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis 6. Serum creatinine = 221 umol/L (2.5 mg/dl) or the need for chronic renal replacement therapy 7. 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Emory University Hospital | Atlanta | Georgia |
United States | Piedmont Heart Institute | Atlanta | Georgia |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | Johns Hopkins Unversity Hospital | Baltimore | Maryland |
United States | Cedars Sinai Medical Center | Beverly Hills | California |
United States | Brigham & Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | University of Chicago Medical Center | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | University Hospitals of Cleveland | Cleveland | Ohio |
United States | Ohio State University Medical Center | Columbus | Ohio |
United States | Baylor Research Institute | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Duke University | Durham | North Carolina |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Shands Hospital @ University of Florida | Gainesville | Florida |
United States | Spectrum Health Butterworth Hospital | Grand Rapids | Michigan |
United States | Hershey | Hershey | Pennsylvania |
United States | Memorial Hermann Health Systems | Houston | Texas |
United States | Methodist Houston | Houston | Texas |
United States | Texas Heart Institute | Houston | Texas |
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 California, San Diego | La Jolla | California |
United States | University of Kentucky - Saha Cardiovascular Research Center | Lexington | Kentucky |
United States | Baptist Health Medical Center - Little Rock | Little Rock | Arkansas |
United States | Jewish Hospital | Louisville | Kentucky |
United States | University of Wisconsin Hospitals and Clinics | Madison | Wisconsin |
United States | St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
United States | University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota |
United States | St. Thomas West Hospital | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Yale New Haven Hospital | New Haven | Connecticut |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Columbia University Medical Center | New York | New York |
United States | Mt. Sinai Medical Center | New York | New York |
United States | Newark Beth Israel Medical Center | Newark | New Jersey |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Florida Hospital | Orlando | Florida |
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 | Oregon Health and Science University | Portland | Oregon |
United States | Bon Secours St. Mary's Hospital | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | University of Rochester Medical Center | Rochester | New York |
United States | Sutter Memorial Hospital | Sacramento | California |
United States | Barnes Jewish Hospital | Saint Louis | Missouri |
United States | University of Utah Hospital and Clinics | Salt Lake City | Utah |
United States | Sharp Memorial Hospital | San Diego | California |
United States | California Pacific Medical Center | San Francisco | California |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | Tampa General Hospital | Tampa | Florida |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices | Thoratec Corporation |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | 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. | As they occur up to 24 months or to Outcome, whichever occurs first | |
Secondary | 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. | Baseline to 24 months | |
Secondary | 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. | Baseline to 24 months | |
Secondary | 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. | Baseline to 24 months | |
Secondary | 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. | Baseline to 24 months | |
Secondary | 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. | Baseline to 24 months | |
Secondary | Rehospitalizations | Rate of all cause rehospitalization | From initial discharge to two years post-implant | |
Secondary | Adverse Event Rates | Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol | Two years post-implant |
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