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

NCT07741383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation Mitral Valve Insufficiency

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-14
Primary Completion
2028-12-31
Completion
2029-12-31

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 NCT07741383 on ClinicalTrials.gov