Actively Recruiting
Efficacy of Burst Stimulation-Guided Ablation Strategy in Improving Single-Procedure Outcomes for Paroxysmal Atrial Fibrillation: A Multicenter, Prospective, Randomized Controlled Study
Led by Zhibing Lu · Updated on 2025-12-15
240
Participants Needed
3
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Paroxysmal atrial fibrillation (PAF) is a common heart rhythm disorder linked to serious health risks like stroke and heart failure. Studies in China show rising rates among people aged 60 and older. While catheter ablation focusing on pulmonary vein isolation (PVI) is a standard treatment for drug-resistant PAF, recurrence rates remain high. Researchers are investigating additional factors, like non-pulmonary vein triggers and atrial remodeling, to improve treatment. This trial explores a novel ablation strategy combining burst stimulation and individualized linear ablation to reduce PAF recurrence and improve patient outcomes. The study compares two groups: one receiving pulmonary vein isolation plus superior vena cava isolation (SVCI) and the other receiving the same plus burst stimulation with individualized linear ablation. The additional procedures aim to target atrial arrhythmias induced during the ablation process. This prospective, multicenter, randomized controlled trial will evaluate the safety and effectiveness of this approach to optimize catheter ablation for PAF. Participants aged 18 to 80 with documented paroxysmal atrial fibrillation scheduled for their first radiofrequency catheter ablation will be enrolled. They will be followed for 12 months with assessments at 1, 3, 6, and 12 months to measure recurrence rates, adverse cardiovascular events, arrhythmia induction during the procedure, and complications. The study includes monitoring quality of life and atrial fibrillation burden to provide a comprehensive evaluation of this personalized ablation method.
CONDITIONS
Brief Title
Burst Stimulation for Paroxysmal Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 80 years old
- Diagnosed with paroxysmal atrial fibrillation that stops on its own and lasts less than 7 days
- Scheduled for first radiofrequency catheter ablation treatment
- Able to provide informed consent and comply with at least 12 months of follow-up
You will not qualify if you...
- Presence of organic heart disease such as rheumatic heart disease, severe valve stenosis or regurgitation, valve replacement, or dilated cardiomyopathy
- Concurrent atrial tachyarrhythmias requiring ablation, including typical atrial flutter and atrial tachycardia
- Prior catheter ablation for any atrial tachyarrhythmia
- Hyperthyroidism, active cancer, or serious illness with life expectancy under 1 year
- Contraindications to anticoagulation
- Inability to stop antiarrhythmic drugs except for atrial fibrillation
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with perioperative period
Participants undergo Pulmonary Vein Isolation (PVI) and Superior Vena Cava Isolation (SVCI), with or without Burst Stimulation and Individualized Linear Ablation, as part of their assigned procedure.
1 procedure visit (in-person) and perioperative assessments
Duration - 12 months
Participants are monitored for recurrence of atrial fibrillation and other outcomes including major adverse cardiovascular events, bleeding events, mortality, and complications.
Follow-up visits at 1, 3, 6, and 12 months
Trial Site Locations
Total: 3 locations
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
2
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441000
Actively Recruiting
3
Yichang Central People's Hospital
Yichang, Hubei, China
Actively Recruiting
Research Team
Z
Zhibing Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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