Comprehensive imaging of valve regurgitation and recurrence risk after atrial fibrillation ablation
Official title: The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation by 3-dimensional Transoesophageal Echocardiography and Recurrent Events Evaluation
Run by First Hospital of China Medical University · NCT07085650 · Data updated 2026-11-12
This project will use 3D transesophageal and transthoracic echocardiography to try to find imaging signs that predict valve regurgitation and which adults with atrial fibrillation planning ablation are more likely to have recurrence.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | First Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Status | Recruiting |
| Started | December 30, 2024 |
| Main results expected | August 31, 2025 |
| Study ends | September 30, 2026 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT07085650 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with atrial fibrillation who plan to undergo their first catheter ablation and can tolerate and produce high-quality 3D-TEE and 3D-TTE images are ideal candidates.
✕Probably not a fit
Patients with prior catheter ablation, significant congenital or valvular heart disease, implanted pacemakers or prosthetic valves, recent thromboembolic events, severe organ failure, or inadequate 3D image quality are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study combines three-dimensional transesophageal (3D-TEE) and transthoracic (3D-TTE) echocardiography to characterize valve regurgitation, annular changes, atrial structure, and left atrial appendage thrombus in patients with atrial fibrillation. Adult patients who present for a first catheter ablation will receive standardized 3D imaging before the procedure and be followed for subsequent recurrence events. Imaging-derived structural and functional metrics will be analyzed to identify predictors of post-ablation AF recurrence and relationships with mitral and tricuspid regurgitation. Patients with poor image quality or major structural heart disease are excluded to ensure reliable 3D measurements.
Why it matters
Potential benefit: If successful, the findings could help clinicians predict which patients are more likely to have AF recurrence after ablation and tailor treatment or follow-up more precisely.
How similar studies have gone: Previous studies using TEE and TTE have linked atrial and valvular changes to AF outcomes, but applying combined 3D-TEE and 3D-TTE specifically to predict post-ablation recurrence is relatively novel and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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First Hospital of China Medical University
Shenyang, Liaoning, China Recruiting
Study contacts
- Study coordinator: Chunyan Ma, Doctor
- Email: cmu1h_mcy@126.com
- Phone: 13998816448
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.