Aug 2nd 2018

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)

SUMMIT is a multicenter randomized clinical investigation which includes a randomized controlled study in which patients with symptomatic, moderately severe or severe mitral regurgitation will be randomized in 1:1 fashion to Tendyne Mitral Valve System (repositionable and retrievable valve composed of 2 self-expanding nitinol frames and a porcine pericardial valve delivered from transapical approach, Abbott Structural, Santa Clara, CA) vs percutaneous mitral valve repair using the MitraClip system. There will also be a non-randomized mitral regurgitation cohort and a mitral regurgitation+mitral annular calcification cohort that will be treated with the Tendyne system. 958 participants will be enrolled. Estimated primary completion: June 2022. Primary outcome for the randomized cohort is survival free of heart failure hospitalization at 12 months. In the early experience of 100 patients at high or prohibitive surgical risk, technical success rate was 96% and, 30-day mortality was 6%. The Tendyne system has received CE mark and is approved for use in Europe.