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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation Mitral Valve Insufficiency
• Intervention / Treatment: Procedure: TEER and Electrical Cardioversion

• Study Type: Interventional
• Enrollment (Estimated): 570
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianan Wang; Phone Number: 0571-87784804; Email: wangjianan111@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Yaping Wang; Phone Number: 86-13805725837; Email: yapingwang@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years;
2. Successful TEER procedure with residual mitral regurgitation grade < 2+;
3. No left atrial thrombus, no severe cardiomyopathy, left atrial anteroposterior diameter < 5.5 cm, and anatomically suitable for electrical cardioversion;
4. Ability to understand the study objectives, voluntarily sign the informed consent form, and willingness to comply with required examinations and clinical follow-up.

Exclusion Criteria:

• 1. Left ventricular ejection fraction < 20%; 2. Stroke or transient ischemic attack within 30 days; 3. Contraindication to anticoagulants, antiplatelet agents, or antiarrhythmic drugs; 4. Severe diseases that may interfere with treatment evaluation, such as severe neurological impairment affecting cognitive function, malignant tumors, etc.; 5. Life expectancy < 12 months; 6. Any other anatomical, concomitant disease, medical, social, or psychological condition that, in the investigator's judgment, may limit the participant's ability to comply with study requirements or affect the scientific validity of the study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEER + Electrical Cardioversion	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.
No Intervention: TEER Alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of All-Cause Death, Heart Failure Rehospitalization, and Stroke	Composite endpoint consisting of: 1) all-cause death (cardiovascular or non-cardiovascular); 2) heart failure rehospitalization, defined as unplanned hospital stay of ≥24 hours due to new or worsening signs/symptoms of heart failure requiring intravenous diuretics, vasoactive therapy, or mechanical support (e.g., IABP, ultrafiltration); and 3) stroke (ischemic, hemorrhagic, or undetermined), confirmed by a neurologist and/or neuroimaging. All events are independently adjudicated by the Clinical Events Committee (CEC) in a blinded manner according to M-VARC definitions.	Within 12 months post-randomization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Electric Stimulation Therapy; Electric Countershock
• Other Study ID Numbers: 2026-1111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No