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RECRUITING
NCT07741383
NA

A Study on the Efficacy and Safety of TEER Combined With Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety and efficacy of combined electrical cardioversion and TEER in patients with severe mitral regurgitation and atrial fibrillation after undergoing TEER. The main objective is to assess the superiority of the combined treatment strategy in reducing the composite endpoints of all-cause mortality, re-hospitalization for heart failure, and stroke within one year, providing high-quality evidence-based medical evidence to optimize the "structural repair + rhythm control" comprehensive intervention strategy for such patients.

Official title: A Study on the Efficacy and Safety of TEER Combined Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation: A Prospective, Multicenter, Open-Label Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2026-07-14

Completion Date

2029-12-31

Last Updated

2026-08-03

Healthy Volunteers

No

Interventions

PROCEDURE

TEER and Electrical Cardioversion

Transcatheter Edge-to-Edge Repair (TEER) followed by immediate electrical cardioversion (ECV) during the same procedure. ECV is performed with synchronized shock at 100-200J, preceded by intravenous amiodarone 300mg. If the first shock fails, a repeated shock up to 200J may be attempted. All patients receive guideline-directed medical therapy (GDMT), anticoagulation, and antiarrhythmic drugs per standard practice.

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China