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Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation

NCT07414225 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-02-17

No results posted yet for this study

Summary

This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.

Conditions

  • Atrial Functional Mitral Regurgitation

Interventions

DEVICE

Transcatheter Edge-to-Edge Repair

The intervention to be implemented in this clinical study is Transcatheter Edge-to-Edge Repair (TEER), a minimally invasive, image-guided interventional procedure specifically designed for the treatment of mitral regurgitation (MR)

Sponsors & Collaborators

  • Beijing Anzhen Hospital

    lead OTHER

Principal Investigators

  • Guangyuan Song, M.D. · Beijing Anzhen Hospital

  • Gregg W. Stone, M.D. · Academic Affairs for the Mount Sinai Heart Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2030-02-25
Completion
2030-02-25

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 NCT07414225 on ClinicalTrials.gov