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NCT Number: NCT07281898

Burst Stimulation for Paroxysmal Atrial Fibrillation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Burst Stimulation

Procedure

Burst Stimulation + Individualized Linear Ablation

Primary outcomes

  1. Recurrence rate

    Time frame: 1-, 3-, 6-, 12-month follow-up

Secondary outcomes

  1. The incidence of major adverse cardiovascular events (MACE), bleeding events, and all-cause mortality

    Time frame: perioperative period and 1-, 3-, 6-, 12-month follow-up

  2. Rate of arrhythmia induction

    Time frame: intra-procedural

  3. Incidence of complications

    Time frame: perioperative period and 1-, 3-, 6-, 12-month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Zhibing Lu

CONTACT

[email protected]

027-67812783

Sponsors and collaborators

Lead sponsor

Zhibing Lu

Other

Registry information

Official study title

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

Acronym: Burst-PAF

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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