The ENCIRCLE Trial is a study to check if the SAPIEN M3 System is safe and works well for people with a heart condition called mitral regurgitation (MR). MR is when the heart's mitral valve doesn't close properly, causing blood to flow backward. The study is for patients who can't have regular surgery or procedures. Participants in this study will join a prospective single-arm, multicenter study, meaning it will include people from different places and only one group will receive the treatment.
- Who can join: Adults 18+, with at least 3+ MR and heart failure symptoms, and no other treatment options.
- Who cannot join: People with certain heart problems, recent heart attacks, severe lung or liver disease, or certain infections.
- What to expect: You must be stable for 30 days before joining and agree to the study rules.
If you qualify, you will be informed about the study and asked to give your consent. You should discuss with your doctor if this study is right for you and understand the risks and benefits before participating.
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