The TRICURE EFS Study is looking at how safe and effective a new tool called the TRiCares Topaz Tricuspid Valve Replacement System is. The tricuspid valve is a part of the heart that helps blood flow correctly. Sometimes, it doesn't work well, which is called tricuspid regurgitation. This study is for adults with severe tricuspid regurgitation (grade 3 on a scale from 0 to 5) who are at higher risk for surgery. The study is being done in several medical centers.

To join, you must be an adult with severe valve problems and have been told by a special heart team that surgery is risky for you. You cannot join if you need an emergency procedure, have unstable health, have an anatomy that doesn't fit the device, or are in another study that isn't finished yet.

• The study will take place at different centers, so you might need to travel.
• There are no emergency cases allowed, so plan ahead if considering participation.
• Check if you meet all the criteria before enrolling to avoid disqualification.