Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical recurrence of atrial fibrillation after catheter ablation
研究概览
简要总结
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for repeat ablation procedure among the patients with recurred atrial fibrillation after de novo catheter ablation. After randomization, we will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation in the other group. Non-pulmonary vein foci ablation will be done in all patients. We will compare clinical recurrence rate, complication rate, and procedure time, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AF aged between 20 and 80 years old.
- •Patients possible to anticoagulation and anti arrhythmic drug
- •Patients who had undergone de novo ablation procedures based on circumferential pulmonary vein isolation with no additional linear ablations
- •Patients undergoing a second ablation procedure due to clinical recurrence resistant to antiarrhythmic drugs with findings of PV reconnections
排除标准
- •1. Structural cardiac disease
- •Contraindication to brain perfusion CT
- •Catheter ablation history for AF, Cardiac surgery for AF
- •active internal bleeding
- •Impossible to anticoagulation or antiarrhythmic drug
- •valvular AF ((MA> GII, Mechanical valve, Mitral valve raplacement)
- •Patients with severe medical disease
- •Expected survival < 1year
- •Severe alcoholics, drug addiction
- •LA diameter>60mm
研究组 & 干预措施
circumferential pulmonary vein isolation
Procedure with circumferential pulmonary vein isolation for atrial fibrillation
干预措施: Procedure with circumferential pulmonary vein isolation (Procedure)
Posterior box isolation in addiction to pulmonary vein isolation
Posterior box isolation in addiction to circumferential pulmonary vein isolation
干预措施: Procedure with linear ablation in addiction to pulmonary vein isolation (Procedure)
结局指标
主要结局
Clinical recurrence of atrial fibrillation after catheter ablation
时间窗: 3 years
We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Any ECG documentation of AF recurrence after 3 months was diagnosed as clinical recurrence.
次要结局
- procedure time(1 day)
- rate of hospitalization(3 years)
- procedure related complication rate(3 years)