The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation

Recruiting

• Conditions: Atrial Fibrillation (AF); Mitral Regurgitation; Tricuspid Regurgitation

• Registration Number: NCT07085650
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the clinic and can lead to valve regurgitation and a poor prognosis. At present, atrial fibrillation ablation is one of the most effective means for the recurrence of atrial fibrillation in clinical practice, but the recurrence rate is high. Therefore, it is of great significance to find the predictors of relapse after atrial fibrillation ablation for clinical precision treatment. three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation.

Therefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.

Detailed Description

Atrial fibrillation (AF) is the most common arrhythmia in clinical practice. It is characterized by disturbance of atrial electromechanical activity, and the incidence rate of the general population can reach 1.5-2%. Valvular regurgitation may be associated with atrial fibrillation, leading to poor prognosis. However, due to limited screening techniques, it is difficult to comprehensively evaluate valvular regurgitation and its influencing factors. On the other hand, AF may lead to reduced heart function, atrial or auricular thrombosis, and lead to high risk events such as ischemic stroke and heart failure.

Therefore, restoring normal sinus rhythm is of great significance for patients with atrial fibrillation. Atrial fibrillation ablation is one of the most effective methods for atrial fibrillation reversion, which is of great significance for improving the prognosis of patients. However, although the current ablation is very mature and effective, the recurrence rate one year after the first ablation can reach 20 to 40%. The high recurrence rate not only increases the readmission risk of patients and increases the economic burden, but also makes some patients shy away from ablation therapy and delay treatment, resulting in adverse outcomes. At present, there is a lack of effective indicators for predicting the recurrence of atrial fibrillation after ablation in clinical practice. Therefore, it is of great significance to search for predictive factors for the recurrence of atrial fibrillation after ablation in clinical precision treatment.

three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation.

Therefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.

Study Timeline

• Study First Submitted: 2024-12-18
• Study Start: 2024-12-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Primary Completion: 2025-08-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Age ≥18 years old;
2. Patients who came to the hospital with atrial fibrillation and intended to undergo ablation.

Exclusion Criteria

1. • History of left atrial or left atrial appendix thrombus, new cerebral infarction and myocardial infarction (< 6 months);
2. Congenital heart disease, valvular heart disease, dilated heart disease, hypertrophic cardiomyopathy, pacemaker implantation, artificial valve replacement;
3. hyperthyroidism, severe liver and kidney insufficiency;
4. Proposed cardiac pacemaker implantation;
5. Previous history of catheter ablation;
6. The quality of three-dimensional transesophageal images was insufficient and could not be analyzed;
7. refuse to sign the informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial fibrillation	3 months after atrial fibrillation ablation	Using 12-lead electrocardiogram and 24h-holter electrocardiogram to exam patients. The recurrence of atrial fibrillation is defined as atrial tachycardia, atrial flutter or atrial fibrillation lasting for 30 seconds or more.

Trial Locations

Locations (1)

First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China