NCT07501234

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Mitrassist Lifesciences Limited Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation (MR)

Interventions

Type	Name	Description
DEVICE	MitraFix® Transcatheter Mitral Valve System	The MitraFix® Transcatheter Mitral Valve System is implanted via a transfemoral-transseptal approach.

Timeline

• Start date: 2026-03-23
• Primary completion: 2028-03-23
• Completion: 2028-10-23
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: China