NCT01088126撤回不适用
Comparison of Linear Ablation Versus Focal Ablation of Complex Fractionated Atrial Electrograms After Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation: A Prospective & Randomized Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- freedom from AF/AT more than 3 months after first ablation
研究概览
简要总结
The end point of catheter ablation at complex fractionated atrial electrograms (CFAE) was not established yet. Furthermore, incomplete CFAE ablation may have a potential to develop atrial tachyarrhythmias (AT). The investigators hypothesized that linear ablation extending the clusters of CFAE would be a better strategy than focal ablation at the individual CFAE sites.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients age 18 or greater
- •persistent atrial fibrillation
- •candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication
- •at least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial
- •continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation
- •patients must be able and willing to provide written informed consent to participate in the clinical trial
排除标准
- •paroxysmal or permanent atrial fibrillation
- •patients with AF felt to be secondary to an obvious reversible cause
- •inadequate anticoagulation as defined in the inclusion criteria
- •left atrial thrombus on TEE prior to procedure
- •contraindications to systemic anticoagulation with heparin or coumadin
- •previously undergone atrial fibrillation ablation
- •patients who are or may potentially be pregnant
研究组 & 干预措施
Focal ablation
Active Comparator
PV isolation + CFAE-targeted focal ablation
干预措施: radiofrequency catheter ablation (Procedure)
Linear ablation
Active Comparator
PV isolation + CFAE-guided linear ablation
干预措施: radiofrequency catheter ablation (Procedure)
结局指标
主要结局
freedom from AF/AT more than 3 months after first ablation
时间窗: 12 months
次要结局
- freedom from AF/AT within 3 months following first ablation(3 months)
- procedure time(12 months)
- acute intra-procedure termination of AF(12 months)
- organization of AF/conversion to AT during the ablation(12 months)
- ablation time(12 months)
- procedure-related complication(12 months)
研究者
研究点 (1)
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