Safety and Performance Study of the TriClip System for Tricuspid Valve Repair in Real-World Use

What this Trial Is About

Researchers are assessing the safety and performance of the TriClip System for treating tricuspid regurgitation in a real-world, contemporary setting. This observational, post-market study involves multiple centers worldwide and uses the commercially available device according to its approved uses to gather real-world data. Participants who are eligible for the TriClip procedure will be enrolled and followed over time. The study includes follow-up visits at hospital discharge, 30 days, 6 months by telephone, 12 months, and then annually up to 5 years. A subset of up to 250 participants will undergo additional imaging with cardiac-gated CT scans at baseline and 12 months to evaluate heart remodeling. An independent core laboratory will review echocardiograms to assess device performance. During the study, participants will undergo clinical assessments before the procedure to confirm eligibility. Researchers will monitor peri-procedural adverse events through 30 days post-procedure and evaluate the grade of tricuspid regurgitation and quality of life improvements at 30 days. Follow-ups over several years will help track long-term safety and device performance. Participants are expected to attend scheduled visits and assessments as part of this evaluation.

A Post-Market Assessment of the Safety and Performance of the TriClip™ System