Cardiovascular Diseases Clinical Trial
— SUMMITOfficial title:
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
| NCT number | NCT03433274 |
| Other study ID # | CS0004-P |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 15, 2018 |
| Est. completion date | June 2028 |
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. 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) is 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 will 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 will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
| Status | Recruiting |
| Enrollment | 958 |
| Est. completion date | June 2028 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC) - NYHA Functional Classification = II (if Class IV, patient must be ambulatory) - The local site heart team determines that the subject has been adequately treated per applicable standards - Not a member of a vulnerable population Exclusion Criteria: - Mitral valvular vegetation or mass - Left ventricular ejection fraction < 25% - Left ventricular end diastolic diameter > 7.0 cm - Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material - Aortic valve disease requiring surgery or transcatheter intervention - Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention - Any planned surgical / interventional procedure within 60 day prior to or following subject randomization - Subject undergoing hemodialysis due to chronic renal failure - Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation - Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months |
| Country | Name | City | State |
|---|---|---|---|
| Canada | The Royal Victoria Hospital | Montreal | Quebec |
| Canada | Montreal Heart Institute | Montréal | Quebec |
| Canada | Ottawa Heart Institute | Ottawa | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| United States | Albany Medical College at Albany Medical Center | Albany | New York |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | Mission Health & Hospitals | Asheville | North Carolina |
| United States | Emory University Hospital | Atlanta | Georgia |
| United States | Piedmont Heart Institute | Atlanta | Georgia |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Cardiothoracic & Vascular Surgeons | Austin | Texas |
| United States | Medstar Health Research Institute | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | Southside Hospital- Northwell Health | Bay Shore | New York |
| United States | Princeton Baptist Medical Center | Birmingham | Alabama |
| United States | UAB University Hospital | Birmingham | Alabama |
| United States | St. Alphonsus Regional Medical Center | Boise | Idaho |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Manatee Memorial Hospital | Bradenton | Florida |
| United States | Buffalo General Hospital | Buffalo | New York |
| United States | Medical University of South Carolina | Charleston | South 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 Virginia Medical Center | Charlottesville | Virginia |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Morton Plant Hospital | Clearwater | Florida |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Baylor Scott & White Heart and Vascular Hospital | Dallas | Texas |
| United States | Medical City Dallas Hospital | Dallas | Texas |
| United States | Delray Medical Center | Delray Beach | Florida |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Fresno Heart Hospital | Fresno | California |
| United States | North Florida Regional Medical Center | Gainesville | Florida |
| United States | Shands at the University of Florida | Gainesville | Florida |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Memorial Hermann Hospital | Houston | Texas |
| United States | St. Vincent Hospital | Indianapolis | Indiana |
| United States | St. Luke's Hospital | Kansas City | Missouri |
| United States | Baptist Health Medical Center | Little Rock | Arkansas |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | University of Southern California University Hospital | Los Angeles | California |
| United States | Catholic Medical Center | Manchester | New Hampshire |
| United States | Wellstar Kennestone Hospital | Marietta | Georgia |
| United States | Baptist Memorial Hospital | Memphis | Tennessee |
| United States | Baptist Hospital of Miami | Miami | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
| United States | The International Heart Institute of Montana | Missoula | Montana |
| United States | West Virginia University | Morgantown | West Virginia |
| United States | Centennial Medical Center | Nashville | Tennessee |
| United States | St. Thomas Hospital | Nashville | Tennessee |
| United States | Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
| United States | Lenox Hill Hospital | New York | New York |
| United States | New York Presbyterian Hospital/ Weill Cornell Medical Center | New York | New York |
| United States | Newark Beth Israel Medical Center | Newark | New Jersey |
| United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
| United States | Banner-University Medical Center | Phoenix | Arizona |
| United States | Alleghany General Hospital - ASRI | Pittsburgh | Pennsylvania |
| United States | UPMC Shadyside | Pittsburgh | Pennsylvania |
| United States | Providence Heart & Vascular Institute | Portland | Oregon |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Beaumont Hospital | Royal Oak | Michigan |
| United States | Sutter Medical Center, Sacramento | Sacramento | California |
| United States | University of California - Davis Medical Center | Sacramento | California |
| United States | St. Louis University Hospital | Saint Louis | Missouri |
| United States | San Diego Cardiac Center | San Diego | California |
| United States | University of California at San Francisco | San Francisco | California |
| United States | HonorHealth Scottsdale Shea Medical Center | Scottsdale | Arizona |
| United States | Swedish Medical Center - Heart & Vascular | Seattle | Washington |
| United States | Adventist HealthCare White Oak Medical Center | Silver Spring | Maryland |
| United States | Prairie Education & Research Cooperative | Springfield | Illinois |
| United States | Stanford Health Care | Stanford | California |
| United States | Tallahassee Research Institute | Tallahassee | Florida |
| United States | Los Robles Hospital and Medical Center | Thousand Oaks | California |
| United States | Oklahoma Heart Institute at Utica | Tulsa | Oklahoma |
| United States | Cleveland Clinic Florida | Weston | Florida |
| United States | Cardiovascular Research Institute of Kansas | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Randomized Cohort | Survival free of heart failure hospitalization at 12 months post index procedure | 1 year | |
| Primary | Non-repairable Cohort | Survival free of heart failure hospitalization at 12 months post index procedure | 1 year | |
| Primary | Severe Mitral Annular Calcification (MAC) Cohort | Survival free of heart failure hospitalization at 12 months post index procedure | 1 year | |
| Primary | Severe MAC Continued Access Protocol (MAC CAP) Cohort | Survival free of heart failure hospitalization at 12 months post index procedure | 1 year | |
| Secondary | Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT) | 1 year | ||
| Secondary | Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 1 year | ||
| Secondary | Change from baseline in health outcomes, as measured by the EQ-5D | 1 year | ||
| Secondary | • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12) | 1 year | ||
| Secondary | Change from baseline in New York Heart Association Classification | 1 year |
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