Association Between Early Recurrence and Long-Term Recurrence After Pulsed Field Ablation for Atrial Fibrillation: Prospective Real-World Evidence From China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Atrial arrhythmias
研究概览
简要总结
The goal of this observational study is to analyze the predictive value of early recurrence within different time windows for late recurrence, ultimately providing evidence-based support for defining the blanking period after pulsed field ablation and stratifying recurrence risk, with the goal of transforming clinical management strategies following pulsed field ablation. The main questions it aims to answer are:
- Employ big data analysis methods to develop a risk stratification tool for atrial fibrillation;
- Identify high-risk prognostic indicators for atrial fibrillation and establish early assessment models for short-term and long-term prognosis.
Participants will undergo pulsed field ablation for the treatment of atrial fibrillation and will receive structured follow-ups at 1, 3, 6, and 12 months post-ablation. At each follow-up, a 24-hour Holter monitor will be performed to systematically assess the recurrence of atrial arrhythmias and the atrial arrhythmia burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years
- •Study participants diagnosed with atrial fibrillation (AF) and scheduled to undergo pulsed field ablation
- •Study participants undergoing their first ablation procedure for AF
排除标准
- •Study participants with any known contraindications to the pulsed field ablation system, anticoagulation therapy, use of contrast agents, or atrial fibrillation ablation
- •Those who have previously undergone atrial fibrillation ablation, or have severe mitral stenosis, valve replacement, or various cardiac surgeries.
研究组 & 干预措施
Pulsed field ablation group
干预措施: pulsed field ablation (Procedure)
结局指标
主要结局
Atrial arrhythmias
时间窗: from 3 months to 12 months post-ablation
Including atrial fibrillation, atrial flutter, and atrial tachycardia, recorded as ≥10 seconds on a 12-lead electrocardiogram or ≥30 seconds on ambulatory electrocardiography (including single-lead patch devices).
次要结局
未报告次要终点
研究者
Bangjiaxin Ren
Attending Physician
West China Hospital