This clinical trial is testing the Tendyne Transcatheter Mitral Valve System, a device for treating symptomatic mitral regurgitation, which is when the heart's mitral valve doesn't close tightly, causing blood to flow backward. The study will compare the Tendyne system to the MitraClip System, another device used for this condition. Patients will be placed into different groups based on their specific condition and needs. The study is looking for patients who have moderate-to-severe or severe mitral regurgitation or severe mitral annular calcification (MAC), which is calcium buildup around the valve.
Participants will be monitored from before the procedure to 5 years after, with visits at 30 days, 3 months, 6 months, and yearly. Eligible patients should have symptoms like difficulty breathing or fatigue and must not have other severe heart issues or be in a vulnerable population.
- Study lasts up to 5 years with multiple check-ups.
- Potential benefits include improved heart function.
- Risks related to the procedure and device use.