A Study on the Efficacy and Safety of TEER Combined With Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEER and Electrical Cardioversion.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation Mitral Valve Insufficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
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.
Primary outcome measures
- Composite of All-Cause Death, Heart Failure Rehospitalization, and Stroke [Time frame: Within 12 months post-randomization]
Eligibility criteria
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%; 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07741383 · 2026-1111