Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)
ProcedurePulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)
NCT Number: NCT07281898
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pulmonary Vein Isolation (PVI) + Superior Vena Cava Isolation (SVCI)
Burst Stimulation + Individualized Linear Ablation
Time frame: 1-, 3-, 6-, 12-month follow-up
Time frame: perioperative period and 1-, 3-, 6-, 12-month follow-up
Time frame: intra-procedural
Time frame: perioperative period and 1-, 3-, 6-, 12-month follow-up
Contact information is provided by the study sponsor or research team.
Zhibing Lu
Other
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
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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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