Study to Test Safety and Use of the MitraFix Transcatheter Mitral Valve System for Adults with Severe Leaky Heart Valve at High Surgical Risk

What this Trial Is About

Researchers are evaluating the MitraFix4 Transcatheter Mitral Valve System in adults with severe mitral regurgitation who are at high risk for traditional open-heart surgery. This early feasibility trial aims to determine if the device is safe, can be successfully implanted, and helps reduce the valve leak to improve daily life. The study is led by MitralAssist Lifesciences Limited Co., Ltd and focuses on patients with moderate-to-severe or severe mitral valve leakage. Participants will receive the MitraFix device implanted via a small tube inserted through a vein in the leg using a transfemoral-transseptal approach. The study involves only one treatment group where all participants receive the device. The device placement is assessed for success during the procedure and after 30 days. Valve performance and other health measures are followed for up to 12 months after implantation. During the study, participants will visit the clinic for heart tests, walking tests, and health evaluations for up to one year after the procedure. Researchers will monitor device success, valve function, changes in heart failure symptoms, quality of life, exercise capacity, hospitalizations, and any adverse events. Follow-up includes assessments such as the New York Heart Association NYHA functional class, Kansas City Cardiomyopathy Questionnaire KCCQ, and 6-minute walk distance to evaluate the devices impact on participants health and daily living.

Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System