Heart and Vascular Clinical Trial - Tendyne Summit

Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive the trial device. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Drug

Device: Tendyne Mitral Valve System Device: Surgical mitral valve repair or replacement

Trial Type

Interventional

Age Range

18 years or older

Condition

Cardiovascular Heart and vascular Mitral Valve Disease Heart Disease

Keywords

Tendyne Mitral Valve System | Mitral valve surgery | Mitral Regurgitation | Mitral Valve Insufficiency