Early return of atrial fibrillation after pulsed field ablation and long‑term risk
Association Between Early Recurrence and Long-Term Recurrence After Pulsed Field Ablation for Atrial Fibrillation: Prospective Real-World Evidence From China
We will see if early return of AF after pulsed field ablation predicts later recurrence in adults having their first ablation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07518966 on ClinicalTrials.gov |
What this trial studies
This prospective, real-world study follows adults undergoing first-time pulsed field ablation for atrial fibrillation at West China Hospital and records arrhythmia using 24-hour Holter monitors at 1, 3, 6, and 12 months post-procedure. Investigators will analyze early recurrence within different time windows and compare those patterns to late recurrence using large-scale data methods. The goal is to develop a risk stratification tool and define an evidence-based blanking period after pulsed field ablation. The work uses single-center clinical data from Chengdu, China to identify prognostic indicators for short- and long-term outcomes.
Who should consider this trial
Good fit: Adults (≥18) with atrial fibrillation scheduled for their first pulsed field ablation who can attend follow-up visits at 1, 3, 6, and 12 months.
Not a fit: Patients with prior AF ablation, contraindications to pulsed field ablation or anticoagulation, severe valvular disease or who cannot return for scheduled Holter monitoring are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, this could help clinicians define the best blanking period after pulsed field ablation and identify patients who need closer follow-up or earlier additional treatment.
How similar studies have performed: Research from thermal ablation suggests early recurrence can predict late recurrence, but pulsed field ablation–specific prospective data are limited, making this approach relatively novel for PFA.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged ≥18 years * Study participants diagnosed with atrial fibrillation (AF) and scheduled to undergo pulsed field ablation * Study participants undergoing their first ablation procedure for AF Exclusion Criteria: * Study participants with any known contraindications to the pulsed field ablation system, anticoagulation therapy, use of contrast agents, or atrial fibrillation ablation * Those who have previously undergone atrial fibrillation ablation, or have severe mitral stenosis, valve replacement, or various cardiac surgeries.
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
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.