Last updated on July 2019

Expanded Clinical Study of the Tendyne Mitral Valve System


Brief description of study

The purpose of this study is to generate initial insights into the safety and performance of the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral regurgitation who are not suitable candidates for conventional mitral valve repair or replacement. The study will include up to 350 subjects at up to 40 centers. Follow-up evaluations will be conducted through 5 years post implantation.

Clinical Study Identifier: NCT02321514

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West Virginia University

Morgantown, WV United States
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Henry Ford Hospital

Detroit, MI United States
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Emory University Hospital

Atlanta, GA United States
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Flinders Medical Center

Bedford Park, Australia
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Morton Plant Mease Health Care

Clearwater, FL United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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MedStar Washington Hospital

Washington, WA United States
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Delray Medical Center

Delray Beach, FL United States
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Abbott Northwestern Hospital

Minneapolis, MN United States
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San Donato

San Donato Milanese, Italy
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St. Antonius Hospital

Nieuwegein, Netherlands
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