This study is testing a new device called the DUO Transcatheter Tricuspid Coaptation Valve System (DUO System) for people with tricuspid regurgitation. Tricuspid regurgitation is a heart condition where the tricuspid valve, which controls blood flow in your heart, doesn't close properly, causing blood to leak backward. The DUO System aims to reduce this leakage using a minimally invasive procedure. We are looking for about 15 adult participants (age 18 or older) who have severe tricuspid regurgitation and are still experiencing symptoms despite other medical treatments. Your heart team will help decide if this study is right for you and if your heart anatomy is suitable. The main goal is to see if the DUO System is safe, by measuring how many participants are free from device or procedure-related major problems within 30 days.

Study design

This is an early feasibility study, meaning it's one of the first studies to test the DUO System in people. It will involve about 15 participants and is not randomized.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The study will collect data on the safety and function of the system, as well as clinical outcomes, for up to 5 years. The primary endpoint for safety is measured at 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.