TRISCEND II Pivotal Trial is a study to check how safe and effective the Edwards EVOQUE tricuspid valve replacement system is. The tricuspid valve is a part of the heart, and when it doesn't close properly, it causes tricuspid regurgitation (TR), meaning blood leaks backward. The study compares the new valve system with the usual medical care, called Optimal Medical Therapy (OMT). Participants will be checked at different times: when they leave the hospital, at 30 days, 3 months, 6 months, and then once a year for 5 years.
Eligibility: To join, you need to have serious symptoms from TR that don't get better with medicine. You can't join if you have certain heart problems, need emergency surgery, or are in another study.
- This study lasts for 5 years with multiple check-ups.
- It is important to confirm if you are suitable for the valve replacement.
- Participation involves regular follow-ups and exams to ensure safety.
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