Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
NCT ID: NCT03433274
Last Updated: 2026-01-08
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
103 participants
INTERVENTIONAL
2018-06-15
2028-06-30
Brief Summary
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The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.
This randomized controlled trial would provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort.
Subjects would be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Randomized Cohort - Treatment Group
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Tendyne Mitral Valve System
Mitral valve replacement
Randomized Cohort - Control Group
Treatment of mitral regurgitation within commercially approved MitraClip system indications
MitraClip System
Percutaneous mitral valve repair using the MitraClip system.
Non-repairable Cohort
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Tendyne Mitral Valve System
Mitral valve replacement
Severe Mitral Annular Calcification (MAC) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
Tendyne Mitral Valve System
Mitral valve replacement
Severe Mitral Annular Calcification Continued Access Plan (MAC CAP) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort
Tendyne Mitral Valve System
Mitral valve replacement
Interventions
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Tendyne Mitral Valve System
Mitral valve replacement
MitraClip System
Percutaneous mitral valve repair using the MitraClip system.
Eligibility Criteria
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Inclusion Criteria
Note: MR and MS severity must be determined by assessment of a qualifying transesophageal echocardiogram (TEE) and transthoracic echocardiogram (TTE), obtained within 120 days prior to subject consent, and must be confirmed by the Echocardiography Core Laboratory.
Note: Patients with severe MAC must have symptomatic mitral valve disease associated with MR≥ Grade III, or severe mitral stenosis (MS), or both moderate MR and moderate MS as assessed by the Echocardiography Core Laboratory.
2. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory).
3. The local site heart team determines that the subject has been adequately treated per applicable standards for coronary artery disease (e.g., revascularization), left ventricular dysfunction (e.g., cardiac resynchronization therapy) and heart failure (e.g., GDMT). The SEC must concur that the subject has been adequately treated.
4. The local site heart team and the SEC concur on the intended study cohort for the subject.
Randomized cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is suitable for TEER and are within approved Mitra Clip indications, which must be confirmed by experienced Mitra Clip operators within the SEC. Subjects with primary MR must be at prohibitive surgical risk, while subjects with secondary MR must be symptomatic despite maximally-tolerated guideline-directed medical therapy and meet the Mitra Clip Indications for Use.
Non-repairable cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is not suitable for TEER with Mitra Clip or does not meet Mitra Clip indications, which must be confirmed by experienced Mitra Clip operators from the SEC.
Severe MAC cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the degree of MAC renders the subject unsuitable for mitral valve surgery.
Severe MAC CAP cohort: Eligibility for this cohort is identical to the original Severe MAC cohort.
5. Age 18 years or older at time of consent.
6. Subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group, complying with trial required testing, medications, and follow-up visits, and has provided written informed consent.
Exclusion Criteria
2. Left Ventricle or Left Atrium thrombus.
3. Chest condition that prevents transapical access.
4. LVEF less than 25% assessed by the site based on a TTE obtained within 120 days prior to subject consent.
Note: LVEF will be principally based on TTE and confirmed by the Echocardiography Core Laboratory.
5. LVEDD \> 7.0 cm assessed by the site based on a TTE obtained within 120 days prior to subject consent.
Note: A qualifying LVEDD must be confirmed by the Echocardiography Core Laboratory.
6. Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material (e.g. valve repair or replacement, or Mitra Clip).
7. Mitral pathoanatomy and LVOT anatomy deemed not suitable for Tendyne transcatheter mitral valve implantation.
8. Aortic valve disease requiring surgery or transcatheter intervention.
9. Tricuspid valve disease requiring surgery or transcatheter intervention.
10. Severe tricuspid regurgitation or severe right ventricular dysfunction.
11. Any surgical or interventional procedure within the period of 60 days prior to or planned procedure 60 days following subject registration.
12. Implant or revision of CRT device within 90 days prior to intended subject registration.
13. Myocardial infarction within 30 days prior to intended subject registration.
14. Symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (e.g., active ischemia) requiring stenting or CABG.
15. CVA within 6 months prior to intended subject registration.
16. Unresolved severe symptomatic carotid stenosis (\> 70% by ultrasound).
17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
18. Hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis.
19. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
20. History of endocarditis within 6 months of planned implant procedure.
21. Active systemic infection requiring antibiotic therapy.
22. Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation or antiplatelet therapy) that cannot be adequately managed medically.
23. Subjects in whom TEE is contraindicated or high risk.
24. Known hypersensitivity to nickel or titanium.
25. Subject is undergoing hemodialysis due to chronic renal failure.
26. Subject has pulmonary arterial hypertension (fixed PAS \>70mmHg). Note: If PAS \> 70mmHg, site must provide documentation PAS is not fixed in order to be eligible.
27. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
28. Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months.
29. Modified Rankin Scale ≥ 4 disability.
30. Status 1 heart transplant or prior orthotopic heart transplantation.
31. Pregnant, lactating, or planning pregnancy during the clinical investigation follow-up period.
Note: Female subjects of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release).
32. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint.
Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
33. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Gorav Ailawadi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Jason Rogers, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Kyle Brunner, PhD
Role: STUDY_DIRECTOR
Abbott Structural Heart
Paul Sorajja, MD
Role: PRINCIPAL_INVESTIGATOR
Allina Health System
Vinod Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Healthcare and the Marcus Heart Valve Center
Locations
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Princeton Baptist Medical Center
Birmingham, Alabama, United States
UAB University Hospital
Birmingham, Alabama, United States
Banner-University Medical Center
Phoenix, Arizona, United States
HonorHealth Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Fresno Heart Hospital
Fresno, California, United States
University of Southern California University Hospital
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
San Diego Cardiac Center
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford Health Care
Stanford, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Morton Plant Hospital
Clearwater, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
North Florida Regional Medical Center
Gainesville, Florida, United States
Shands at the University of Florida
Gainesville, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
MedStar Health Research Institute
Balitmore, Maryland, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Adventist HealthCare White Oak Medical Center
Silver Spring, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
The International Heart Institute of Montana
Missoula, Montana, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Albany Medical College at Albany Medical Center
Albany, New York, United States
South Shore University Hospital
Bay Shore, New York, United States
Buffalo General Hospital
Buffalo, New York, United States
New York Presbyterian Hospital/ Weill Cornell Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Mission Health & Hospitals
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health Heart and Vascular Research Institute
Charlotte, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Cardiothoracic & Vascular Surgeons
Austin, Texas, United States
Baylor Scott & White Heart and Vascular Hospital
Dallas, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Swedish Medical Center - Heart & Vascular
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Ottawa Heart Institute
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Institute)
Montreal, Quebec, Canada
The Royal Victoria Hospital
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CS0004-P
Identifier Type: -
Identifier Source: org_study_id
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