Burst stimulation with pulmonary vein and superior vena cava isolation for paroxysmal atrial fibrillation

Efficacy of Burst Stimulation-Guided Ablation Strategy in Improving Single-Procedure Outcomes for Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Controlled Study

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Locations: 3 sites (Wuhan, Hubei and 2 other locations)
• Trial ID: NCT07281898 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Wuhan, Hubei and 2 other locations

• 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

Conditions Paroxysmal Atrial Fibrillation