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

NCT07741383 | Recruiting

• 1 other identifier: 2026-1111
• Study Type: interventional
• Target: 570
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

TEER + Electrical Cardioversion

EXPERIMENTAL

Procedure: TEER and Electrical Cardioversion

TEER Alone

NO INTERVENTION

Interventions

TEER and Electrical Cardioversion PROCEDURE

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.

TEER + Electrical Cardioversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Electric Countershock

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Central Study Contacts

Jianan Wang

CONTACT

0571-87784804; wangjianan111@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)