Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) + Burst Stimulation + Individualized Linear Ablation |
|
| Control group | Active Comparator | Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) | Procedure | Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | 1-, 3-, 6-, 12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhibing Lu | Contact | 027-67812783 | luzhibing222@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
In order to protect the privacy of participants, the individual participant data (IPD) from this study will not be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Burst Stimulation | Procedure | Burst Stimulation + Individualized Linear Ablation |
|
| Incidence of complications | perioperative period and 1-, 3-, 6-, 12-month follow-up |
| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441000 | China |
|
| Yichang Central People's Hospital | Recruiting | Yichang | Hubei | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |