Burst Stimulation for Paroxysmal Atrial Fibrillation

NCT07281898 | Recruiting DMC

• 1 other identifier: 2025198
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  1-, 3-, 6-, 12-month follow-up

Secondary Outcomes (3)

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

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

• Rate of arrhythmia induction

  intra-procedural

• Incidence of complications

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

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

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

Interventions

Burst Stimulation PROCEDURE

Burst Stimulation + Individualized Linear Ablation

Test group

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

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

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhibing Lu: lead

Study Sites (3)

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

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhibing Lu

CONTACT

027-67812783; luzhibing222@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The chief of cardiology department

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 15, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)