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.
Moderate to severe or severe (≥3+) mitral regurgitation.
Age ≥ 18 years.
Patients at high risk for traditional open-heart surgery, defined as: STS mortality risk for mitral valve replacement ≥ 8%; OR presence of 2 or more frailty indices; OR presence of 2 or more major organ dysfunctions that cannot be improved post-operatively; OR other comorbidities or factors making them unsuitable for surgery.
Anatomically suitable for transcatheter MitraFix® system implantation via a transfemoral-transseptal approach as assessed by the investigator; the transfemoral-transseptal access route meets the requirements of the delivery system.
Severe mitral stenosis.
Severe calcification of mitral leaflets and/or annulus; anatomical structures of the mitral valve apparatus (e.g., papillary muscles) unsuitable for device implantation.
High risk of left ventricular outflow tract obstruction (LVOTO) based on pre-operative CT/TEE planning (estimated neo-LVOT < 150 mm²), which cannot be avoided by procedural optimization.
Presence of previous implants in the mitral position (surgical bioprosthetic or mechanical valves, surgical annuloplasty rings, etc.).