NCT01711047已完成不适用
A Study to Investigate the Benefit Of Complex Fractionated Atrial Electrogram (CFAE) Ablation in Addition to Circumferential Pulmonary Vein and Linear Ablations in the Treatment of Persistent Atrial Fibrillation. (BOCA)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Single procedural success rate (free from AF off anti-arrhythmic drugs)
研究概览
简要总结
The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent atrial fibrillation
排除标准
- •previous catheter or surgical ablation for atrial fibrillation
- •pregnancy
研究组 & 干预措施
PVI + Linear ablation
Active Comparator
Arm A: patients have PVI and roof and mitral isthmus lines
干预措施: Radiofrequency catheter Ablation (Procedure)
PVI + linear ablation + CFAE
Active Comparator
Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation
干预措施: Radiofrequency catheter ablation (Procedure)
结局指标
主要结局
Single procedural success rate (free from AF off anti-arrhythmic drugs)
时间窗: 12 MONTHS
次要结局
- Percentage of AF termination(Time 0)
- recurrence of atrial fibrillation or organised atrial tachycardia(12 months after the last procedure)
- Ablation time(Time 0)
- Procedure time(Time 0)
- Multiple procedure success rate(12 months after last ablation)
- Complication rate(30 days of procedure)
研究者
研究点 (3)
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