The TRISCEND II Pivotal Trial is a study to test a new heart valve replacement system called the Edwards EVOQUE. This system is for people with severe tricuspid regurgitation (TR), a condition where the valve between the right heart chambers doesn't close properly, causing blood to flow backward. This study will compare the EVOQUE system with the best current medical treatment alone. Participants will have check-ups at discharge, 30 days, 3 months, 6 months, and then once a year for up to 5 years.
Who can join? People with severe TR symptoms that don’t improve with medicine and are suitable for this valve replacement. You cannot join if you have certain valve issues, need emergency surgery, have unstable heart conditions, or are in another study.
- Length: Follow-ups for up to 5 years.
- Visits: Several check-ups including discharge and regular intervals.
- Risks/Treatment: Testing a new heart valve system versus medicine.
If you have severe TR and qualify, this study might offer a new treatment option.