Early Feasibility Study of the DUO Transcatheter Valve System for Treating Tricuspid Regurgitation in Adults

What this Trial Is About

Researchers are evaluating the DUO Transcatheter Tricuspid Coaptation Valve System DUO System in patients with severe tricuspid regurgitation who remain symptomatic despite medical therapy. This early feasibility study aims to measure individual patient clinical outcomes, assess the safety and function of the DUO System, and collect data on up to 5 years of clinical results. The study is multi-center, prospective, non-randomized, and conducted before market approval to gather key information about the devices performance. Participants will receive treatment with the DUO System, which is designed to reduce tricuspid regurgitation through a transcatheter approach. The study does not randomize or blind participants and focuses on evaluating the investigational devices safety and function. The treatment period includes initial device implantation and monitoring, with follow-up visits planned to assess both short-term and long-term outcomes. During the study, participants will undergo evaluations to monitor device safety, function, and clinical outcomes, including assessments of freedom from major adverse events related to the device or procedure at 30 days. Researchers will collect clinical data over a period that may extend to 5 years to understand the devices effectiveness and safety profile. Participants will be monitored regularly through clinical visits and assessments to ensure comprehensive data collection and safety oversight throughout the study period.

EFS of the DUO System for Tricuspid Regurgitation