MiCLASP PMCF Study

Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System: A European prospective, multicenter Post Market Clinical Follow up.

22/01/2021 to 30/06/2027

Study Hypothesis
The Edwards PASCAL Transcatheter Valve Repair System will reduce the severity of MR at discharge, with durable performance at 12 months and improvements in functional status as determined by changes in 6MWD, NYHA classification and quality of life.

Study Objectives
The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and on the effectiveness of the PASCAL System in improving MR and improving functional status and quality of life in a post market setting.

Study Design and Methods
Multi-center single arm prospective study. Patients will be followed for up to 5 years.