Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07281898

Burst Stimulation for Paroxysmal Atrial Fibrillation

Led by Zhibing Lu · Updated on 2025-12-15

240

Participants Needed

3

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Burst Stimulation for Paroxysmal Atrial Fibrillation

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18 to 80 years old
  • Documented diagnosis of paroxysmal atrial fibrillation lasting less than 7 days
  • Scheduled for initial radiofrequency catheter ablation treatment
  • Able to provide informed consent and comply with at least 12 months of follow-up
Not Eligible

You will not qualify if you...

  • Presence of organic heart disease such as rheumatic heart disease, severe valve stenosis or regurgitation, post-valve replacement, or dilated cardiomyopathy
  • Other atrial tachyarrhythmias requiring ablation including typical atrial flutter or atrial tachycardia
  • Previous catheter ablation for any atrial tachyarrhythmia
  • Hyperthyroidism, active cancer, or serious illness with life expectancy under 1 year
  • Contraindications to anticoagulation therapy
  • Unable to stop antiarrhythmic drugs except for atrial fibrillation treatment
  • Pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China, 430071

Actively Recruiting

2

Xiangyang Central Hospital

Xiangyang, Hubei, China, 441000

Actively Recruiting

3

Yichang Central People's Hospital

Yichang, Hubei, China

Actively Recruiting

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Research Team

Z

Zhibing Lu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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