Six-Month And One-Year Outcomes For Transcatheter Repair In Patients With Mitral Regurgitation From The Clasp Study

ABSTRACT Background The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. Objectives We report the CLASP study expanded experience, one-year outcomes, and analysis by functional and degenerative MR (FMR; DMR). Methods Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to one year. Results 109 patients were treated (67% FMR, 33% DMR), mean age was 75.5 years, and 57% were in New York Heart Association (NYHA) class III/IV. At 30 days, there was one cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR; 86% DMR) and ≤2+ in 96% (96% FMR; 97% DMR), 88% were NYHA class I/II, 6-minute walk distance improved 28m, Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved 16 points [all p Conclusions The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at one year.