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.).
Single group
MitraFix® Transcatheter Mitral Valve System
DeviceThe MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.
Device Success Rate
evice success is defined as the patient being alive and free from stroke, with the implanted valve in the intended position and functioning properly, without the need for re-operation or re-intervention due to device-related complications.
Technical Success Rate
Percentage of participants achieving technical success, defined as successful access, delivery, and deployment of the device, and successful retrieval of the delivery system.
Procedural Success Rate
Percentage of participants achieving procedural success, typically defined as technical success without the occurrence of major device- or procedure-related serious adverse events.
Valve Performance Assessment
Evaluated by echocardiography, including the severity of residual mitral regurgitation, transvalvular pressure gradient, and the presence/severity of paravalvular leak.
Change in New York Heart Association (NYHA) Functional Class
Assessment of clinical improvement in heart failure symptoms based on the NYHA classification (Class I to IV, where a lower class indicates better function).
Click on the lead sponsor to view all of their trials.
