NCT02721121Unknown不适用
Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- 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 persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators 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 persistent Atrial fibrillation (20~80 years)
- •LA diameter <55mm
- •patients possible to anticoagulation and anti arrhythmic drug
排除标准
- •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 replacement)
- •Patients with severe medical disease
- •Expected survival < 1year
- •Severe alcoholics, drug addiction
研究组 & 干预措施
circumferential pulmonary vein isolation
Active Comparator
circumferential pulmonary vein isolation
干预措施: circumferential pulmonary vein isolation (Procedure)
Linear ablation in addiction to pulmonary vein isolation
Experimental
Linear ablation in addiction to pulmonary vein isolation
干预措施: Linear ablation in addiction to circumferential pulmonary vein isolation (Procedure)
结局指标
主要结局
Recurrence of atrial fibrillation after catheter ablation
时间窗: 12 month
次要结局
- rate of hospitalization(12 month)
- procedure related complication rate(12 month)
- procedure time(1 day)
研究者
研究点 (1)
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