This study is testing a new device called the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System. It's for people who have severe, symptomatic tricuspid regurgitation (a condition where the heart's tricuspid valve doesn't close properly, causing blood to leak backward). The study aims to see if the Laplace TTVR System is safe and technically possible to use. You might be able to join if you are between 18 and 90 years old and have severe tricuspid regurgitation that hasn't improved with other treatments. The main goal is to see if the procedure is successful during the operation. The current recruitment status is unclear, and the study plans to enroll 65 participants.

Study design

This is an early feasibility study, meaning it's one of the first times this device is being tested in humans. It's a single-arm study, which means everyone receives the Laplace TTVR System, and it plans to enroll 65 participants.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The primary goal of the study is to assess technical success during the procedure itself.

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