Safety and Feasibility Study of the MitraFix® Transcatheter Mitral Valve System
A Prospective Clinical Study to Evaluate the Safety and Clinical Feasibility of the MitraFix® Transcatheter Mitral Valve System
Mitrassist Lifesciences Limited Co., Ltd.
5 participants
Mar 23, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07501234