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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