This study is testing a new medical device called the Trisol System. It's designed to help people with a heart problem called tricuspid regurgitation (TR), which is when the heart's tricuspid valve leaks and doesn't close properly. The study will see how safe and effective the Trisol System is for treating TR.
The study is for adults over 18 who have moderate or worse TR and are at high risk for surgery. Participants should have tried other heart treatments for at least 30 days. You must be able to follow study rules and attend follow-up appointments.
Some people cannot join. This includes those who had certain heart surgeries or problems like recent heart attacks, strokes, or infections. If your heart or blood conditions aren't stable, you may also be excluded.
- The study is conducted at multiple centers, meaning you might need to travel for appointments.
- You will be closely monitored during the study to ensure safety.
- There may be risks due to the newness of the device, but the study aims to understand these better.