Safety and Effectiveness Study of Edwards PASCAL Transcatheter Valve Repair Systems for Mitral Valve Repair A European Prospective Post Market Clinical Follow-Up

What this Trial Is About

Researchers are collecting data to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing the mitral valve through a minimally invasive procedure called transcatheter mitral valve repair. The study focuses on patients with mitral regurgitation to understand how well these devices improve valve function, symptoms, and quality of life in real-world settings after market approval. Participants receive treatment using either the Edwards PASCAL System or the Edwards PASCAL Precision System for transcatheter mitral valve repair. This study is conducted in a postmarket clinical follow-up format, meaning the devices are already approved and are now being further studied to gather safety and effectiveness data over time. During the study, patients will be monitored for major adverse events within 30 days and assessed for changes in mitral regurgitation severity by echocardiography at discharge or 7 days after the procedure. Participants will also attend follow-up visits where functional status and quality of life will be evaluated. The study aims to collect comprehensive safety and effectiveness information over the course of participation, which begins after the mitral valve repair procedure and continues through scheduled follow-ups.

MiCLASP Post Market Clinical Follow-Up (PMCF) Study