This study is testing a new device called the TRiCares Topaz Tricuspid Valve Replacement System. This system replaces the tricuspid valve (one of the heart's four valves) using a catheter, which is a thin, flexible tube. The study aims to see how safe and effective this new device is for people with severe tricuspid regurgitation (a condition where the tricuspid valve doesn't close properly, causing blood to leak backward). You might be able to join if you are an adult with severe tricuspid regurgitation and your heart team believes surgery is too risky for you. The study will measure success by looking at any major problems within 30 days after the procedure and how well the device works immediately after it's put in. The current recruitment status is unclear.

Study design

This is a multi-center study that will enroll 15 adult patients. It is a single-arm study, meaning all participants receive the same intervention.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for at least 30 days after the intervention.

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