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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 570
- Locations
- 1
- Primary Endpoint
- Composite of All-Cause Death, Heart Failure Rehospitalization, and Stroke
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •1. Left ventricular ejection fraction < 20%;
- •Stroke or transient ischemic attack within 30 days;
- •Contraindication to anticoagulants, antiplatelet agents, or antiarrhythmic drugs;
- •Severe diseases that may interfere with treatment evaluation, such as severe neurological impairment affecting cognitive function, malignant tumors, etc.;
- •Life expectancy < 12 months;
- •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
Time Frame: Within 12 months post-randomization
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.
Secondary Outcomes
No secondary outcomes reported