Burst Stimulation for Paroxysmal Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-13

Study Completion Date

2028-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Test group

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

Group Type EXPERIMENTAL

Burst Stimulation

Intervention Type PROCEDURE

Burst Stimulation + Individualized Linear Ablation

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

Intervention Type PROCEDURE

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

Control group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Interventions

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Burst Stimulation

Burst Stimulation + Individualized Linear Ablation

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No