Study to Test Safety and Effectiveness of Edwards PASCAL System for Treating Severe Tricuspid Regurgitation Compared to Medical Therapy Alone in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with symptomatic severe tricuspid regurgitation who are at intermediate or higher risk of death from tricuspid valve surgery. This prospective, multicenter, randomized, controlled pivotal trial compares transcatheter tricuspid valve repair plus optimal medical therapy OMT to OMT alone. The study aims to improve outcomes in patients with severe tricuspid valve disease through this novel treatment approach. Participants will be randomly assigned to receive either the Edwards PASCAL transcatheter valve repair system combined with OMT or OMT alone. Some patients who are not eligible for randomization may still receive the Edwards PASCAL system with OMT in single-arm or continued access study groups. Follow-up visits will be conducted at hospital discharge, 30 days, 3 months, 6 months, and annually up to 5 years to monitor progress and outcomes. During the study, participants will undergo assessments including quality of life questionnaires, heart function measurements, and monitoring for events such as mortality, heart failure hospitalizations, and need for additional heart interventions. Researchers will track changes in tricuspid regurgitation severity and right ventricular size, as well as major adverse events. The primary outcome focuses on a composite of mortality, heart device implantation or transplant, valve interventions, hospitalizations, and quality of life improvements at 6 months. Safety and effectiveness will be evaluated throughout the study duration, which may last up to 12 years.

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial