Burst stimulation with pulmonary vein and superior vena cava isolation for paroxysmal atrial fibrillation
Official title: Efficacy of Burst Stimulation-Guided Ablation Strategy in Improving Single-Procedure Outcomes for Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Controlled Study
Run by Zhongnan Hospital · NCT07281898 · Data updated 2026-11-12
This will try burst electrical stimulation together with pulmonary vein and superior vena cava isolation to lower the chance that paroxysmal atrial fibrillation comes back after a first catheter ablation in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Zhongnan Hospital Academic / other |
| Locations | 3 sites (Wuhan, Hubei and 2 other locations) |
| Status | Recruiting |
| Started | October 13, 2025 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT07281898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 years old with documented self‑terminating paroxysmal atrial fibrillation who are scheduled for their first radiofrequency catheter ablation and can comply with 12 months of follow‑up.
✕Probably not a fit
Patients with persistent AF, prior catheter ablation, significant structural (organic) heart disease, contraindications to anticoagulation, active serious comorbidities with life expectancy under one year, or inability to stop antiarrhythmic drugs 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
Patients with paroxysmal atrial fibrillation scheduled for their first radiofrequency catheter ablation will undergo pulmonary vein isolation plus superior vena cava isolation with intra‑procedural burst electrical stimulation to provoke and target arrhythmia triggers. The protocol enrolls adults aged 18–80 without significant organic heart disease or prior atrial ablation and requires stopping antiarrhythmic drugs when possible. Participants will be followed for at least 12 months for arrhythmia recurrence and safety outcomes. The main outcomes include AF recurrence rates and procedure‑related complications over the follow‑up period.
Why it matters
Potential benefit: If successful, this approach could lower AF recurrence after ablation and reduce the need for repeat procedures, and potentially decrease stroke and heart‑failure risk associated with recurrent AF.
How similar studies have gone: Prior work shows pulmonary vein isolation alone has 30–50% long‑term recurrence, and targeting non‑pulmonary vein sources like the superior vena cava and using burst stimulation to elicit triggers has shown mixed but promising results without broad validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18 to 80 years old; * Documented diagnosis of paroxysmal atrial fibrillation (self-terminating and lasting \< 7 days); * Patients scheduled for initial radiofrequency catheter ablation (RFCA) treatment; * Able to sign the informed consent form and comply with a minimum of 12 months of follow-up. Exclusion Criteria: * Presence of organic heart disease (e.g., rheumatic heart disease, severe valvular stenosis or regurgitation, post-valve replacement, or dilated cardiomyopathy); * Concomitant atrial tachyarrhythmia requiring radiofrequency ablation (including typical atrial flutter and atrial tachycardia); * Prior history of catheter ablation for any atrial tachyarrhythmia (including atrial fibrillation, atrial flutter, or atrial tachycardia); * Concomitant hyperthyroidism, active malignant tumor, or other serious illness with a life expectancy of \<1 year; * Contraindications to anticoagulation; * Inability to discontinue antiarrhythmic drugs for reasons other than atrial fibrillation; * Pregnant or breastfeeding women.
Where it's running
-
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China Recruiting -
Xiangyang Central Hospital
Xiangyang, Hubei, China Recruiting -
Yichang Central People's Hospital
Yichang, Hubei, China Recruiting
Study contacts
- Study coordinator: Zhibing Lu
- Email: luzhibing222@163.com
- Phone: 027-67812783
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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.