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NOT YET RECRUITING
NCT07414225
NA

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

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation - The STAR Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-02-25

Completion Date

2030-02-25

Last Updated

2026-02-17

Healthy Volunteers

No

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)

Locations (1)

Interventional Center of Valvular Heart Disease, Beijing Anzhen Hospital

Beijing, Beijing Municipality, China