Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

NCT Number	NCT04097145
Lead Sponsor	Edwards Lifesciences
Conditions	Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
Enrollment	1,270 participants
Start Date	2019-12-11
Primary Completion	2027-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-06