CLASP IID/IIF is a randomized, multicenter trial of the Edwards PASCAL transcatheter mitral valve repair system (mitral repair with broad paddles, 3D maneuvering, independent leaflet capture, Edwards Lifesciences, Irvine, CA) in patients with severe symptomatic mitral regurgitation at prohibitive risk for mitral valve surgery in degenerative MR or in patients with functional MR on guideline directed medical therapy. The control arms will include patients treated using the MitraClip system (Abbott Structural, Santa Clara, CA). Randomization is in 1:1 fashion, stratified by mechanism of mitral regurgitation (degenerative or functional). 1275 participants will be included in this study. Estimated primary completion date: December 2023. Primary outcome measures are major adverse events at 30 days, mitral regurgitation severity reduction at 6 months and recurrent heart failure hospitalization and all-cause mortality at 24 months.
All Editors: Kalkidan Bishu, MD, MS, FSCAI
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