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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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jianan Wang
wangjianan111@zju.edu.cn
0571-87784804
Time Frame
Start Date: 2026-07-14
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 570
Treatments
Experimental: TEER + Electrical Cardioversion
No_intervention: TEER Alone
Sponsors
Leads: Second Affiliated Hospital, Zhejiang University, School of Medicine

This content was sourced from clinicaltrials.gov