Study of Tangent Tricuspid Annular Therapy System for Treating Severe Symptomatic Functional Tricuspid Regurgitation Evaluating Safety and Technical Success of Transcatheter Valve Repair

What this Trial Is About

This trial evaluates the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation. The study focuses on patients who have this condition despite optimal medical therapy and aims to assess device-related major adverse events and technical efficacy. Participants will receive the experimental Tangent device designed for transcatheter tricuspid valve repair. The study is single-arm and prospective, with safety and technical performance measured during and after the procedure, including hospital discharge assessments. Participants will undergo follow-up visits at 30 days, 90 days, 180 days, and 365 days post-procedure. During these visits, researchers will assess safety endpoints, technical success, functional class, quality of life, walking ability, and tricuspid regurgitation severity. The total participation may last up to one year after the procedure, with careful monitoring of outcomes and device performance.

Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation