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

NCT07501234 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-03-30

No results posted yet for this study

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

DEVICE

MitraFix® Transcatheter Mitral Valve System

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

Sponsors & Collaborators

  • Mitrassist Lifesciences Limited Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2028-03-23
Completion
2028-10-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501234 on ClinicalTrials.gov