Clinical Study of the inQB8 TTVR System
This study is testing a new system called the inQB8 MonarQ Tricuspid Valve Replacement System. The tricuspid valve is a part of the heart that helps blood flow properly. Tricuspid regurgitation (TR) means this valve is not working well, causing blood to flow backward. The study checks if the system is safe and works well for people with severe TR.
To join, you need to have certain health conditions: your heart must be stable, and you should have been treated for heart failure according to medical guidelines. You cannot join if you need urgent heart surgery soon, have a heart condition that needs special treatment, or are part of a different medical study.
Key Points:
- The study takes place at several locations and follows participants over time to see results.
- Participants must be stable and previously treated for heart conditions.
- You cannot join if you have scheduled heart procedures or are in another study.
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