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

Second Affiliated Hospital, Zhejiang University, School of Medicine570 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

570

Conditions

Atrial Fibrillation Mitral Valve Insufficiency

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Within 12 months post-randomization