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RecruitingNCT07281898Burst-PAFUpdated Dec 15, 2025

Burst Stimulation for Paroxysmal Atrial Fibrillation

An interventional study of Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) and Burst Stimulation in Paroxysmal Atrial Fibrillation, sponsored by Zhibing Lu. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Zhibing Lu · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 240 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Zhibing Lu is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Test group

    Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) + Burst Stimulation + Individualized Linear Ablation

    Procedure: Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) · Procedure: Burst Stimulation

  • Active comparator
    Control group

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

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

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

06

What researchers measure

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

07

Study locations

3 of 3 sites recruiting
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei 430071, China
    Recruiting
  • Xiangyang Central Hospital
    Xiangyang, Hubei 441000, China
    Recruiting
  • Yichang Central People's Hospital
    Yichang, Hubei, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — In order to protect the privacy of participants, the individual participant data (IPD) from this study will not be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07281898
Lead sponsor
Zhibing Lu
Responsible party
Zhibing Lu (The chief of cardiology department, Zhongnan Hospital) — Sponsor-investigator
First posted
Dec 15, 2025
Start date
Oct 13, 2025
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Dec 15, 2025

Study contacts

Zhibing Lu
Contact
luzhibing222@163.com
027-67812783

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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