Comprehensive imaging of valve regurgitation and recurrence risk after atrial fibrillation ablation
The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation by 3-dimensional Transoesophageal Echocardiography and Recurrent Events Evaluation
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Hospital of China Medical University Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT07085650 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shenyang, Liaoning
- First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Chunyan Ma, Doctor
- Email: cmu1h_mcy@126.com
- Phone: 13998816448
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.