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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Condition: Mitral Regurgitation · Mitral Insufficiency · Mitral Valve Insufficiency · Sponsor: Abbott Medical Devices
About this study
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were 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 were 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) 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 v…
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
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Locations (78)
| Baptist Medical Center Princeton | Birmingham, Alabama, United States | — |
| UAB University Hospital | Birmingham, Alabama, United States | — |
| Banner-University Medical Center | Phoenix, Arizona, United States | — |
| Scottsdale Healthcare Shea | 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 | — |
+ 66 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03433274