RecruitingNot ApplicableNCT07281898

Burst Stimulation 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


Sponsor

Zhibing Lu

Enrollment

240 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Atrial fibrillation (AF) is one of the most common cardiac arrhythmias worldwide, associated with high morbidity and mortality rates. Epidemiological studies in China show that the prevalence of AF in individuals aged ≥60 years ranges from 2% to 3%, with rates continuing to rise due to population aging. Paroxysmal atrial fibrillation (PAF), if inadequately controlled, tends to progress to persistent AF, significantly increasing the risk of stroke, heart failure, and death. Catheter ablation has become a first-line therapy for drug-refractory PAF, with pulmonary vein isolation (PVI) recognized as the cornerstone procedure. However, multiple prospective studies and meta-analyses indicate that long-term recurrence rates following PVI alone remain as high as 30%-50%. This observation has prompted researchers to investigate the roles of non-pulmonary vein triggers, atrial remodeling, and electrophysiological substrate in PAF recurrence. The superior vena cava (SVC) has been identified as a common non-pulmonary vein trigger, with empirical SVC isolation demonstrating additional clinical benefits in select studies. Furthermore, the presence of atrial electrical remodeling and reentry-dependent substrate suggests that trigger-focused ablation strategies alone may be insufficient to prevent recurrence in certain PAF patients. Burst pacing-induced atrial tachyarrhythmias, such as atrial flutter or fibrillation, provide a practical method for assessing atrial substrate. Retrospective studies indicate that additional linear ablation targeting procedure-induced atrial tachycardias, such as typical atrial flutter, can significantly reduce PAF recurrence rates. However, this strategy currently lacks high-quality evidence from prospective randomized controlled trials. To date, no large-scale randomized controlled trial (RCT) has systematically validated the impact of programmed burst pacing combined with individualized linear ablation on outcomes in PAF patients, nor have standardized induction protocols or supplementary ablation pathways been established. This study addresses a critical need for optimized treatment strategies in the field of catheter ablation, with significant clinical implications and potential for widespread application. Therefore, this prospective, multicenter, randomized controlled trial aims to systematically evaluate the efficacy and safety of this strategy in reducing post-ablation PAF recurrence, improving quality of life, and controlling AF burden. The study seeks to fill the current evidence gap and advance AF treatment from standardized protocols toward individualized precision intervention.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using short bursts of electrical stimulation during a catheter ablation procedure improves outcomes for people with paroxysmal atrial fibrillation — a heart rhythm disorder where the heart beats irregularly in episodes that start and stop on their own. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with paroxysmal atrial fibrillation (episodes lasting less than 7 days that stop on their own) - This is your first time undergoing radiofrequency catheter ablation for atrial fibrillation - You can attend follow-up visits for at least 12 months **You may NOT be eligible if...** - You have structural heart disease (such as valve problems or dilated cardiomyopathy) - You have other heart rhythm problems that also need ablation (like atrial flutter) - You have had a previous catheter ablation for any heart rhythm condition - You have uncontrolled high blood pressure or other conditions that make ablation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)

Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)

PROCEDUREBurst Stimulation

Burst Stimulation + Individualized Linear Ablation


Locations(3)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Yichang Central People's Hospital

Yichang, Hubei, China

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NCT07281898


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