This study is testing a new heart device called the Tendyne Transcatheter Mitral Valve System, which helps people with a heart problem called *mitral regurgitation*. Mitral regurgitation happens when the heart's mitral valve doesn't close tightly, causing blood to flow backward. The study will compare this new device to another device called the MitraClip. People who have another heart problem called *severe mitral annular calcification* (a hardening of the heart tissue) and can't have surgery will also be tested with the Tendyne device.

Key Points:

• The study lasts up to 5 years with several visits including screening, procedure, and follow-ups.
• Participants will be randomly chosen to receive either the Tendyne device or the MitraClip, except for some who will only get Tendyne.
• Participants need to meet certain health criteria, like having moderate to severe mitral regurgitation, and can't have certain other heart conditions.

If you have these heart conditions and are interested, this study might help doctors learn which device works best for people like you. However, it involves a long-term commitment and several doctor visits.