The goal of this early feasibility clinical trial is to test a new device called the MitraFix® Transcatheter Mitral Valve System. It aims to learn if the device is safe and if it can help adults who have a severe leaky heart valve (mitral regurgitation). This study is for people who are at high risk for traditional open-heart surgery.
The main questions it aims to answer are:
Is the MitraFix system safe for participants? Can the device be successfully placed in the heart? Does the device help reduce the valve leak and improve daily life?
Participants will:
Receive the MitraFix valve through a small tube inserted into a vein in the leg.
Visit the clinic for heart tests, walking tests, and health checks for up to one year after the procedure.