A Study on the Efficacy and Safety of TEER Combined With Electrical Cardioversion in Patients With Severe Mitral Regurgitation and Atrial Fibrillation
Recruiting · NCT07741383 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
TEER and Electrical Cardioversion
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- The Second Affiliated Hospital Zhejiang University School of Medicine - Hangzhou, Zhejiang, China