NCT01794416已完成2 期
Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- freedom from any atrial arrhythmia
研究概览
简要总结
The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.
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 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •failed initial catheter ablation
- •paroxysmal atrial fibrillation
排除标准
- •chronic lung disease
- •body mass index >35
- •longstanding atrial fibrillation 1 year
- •previous stroke or transient ischemic attack
- •left atrial thrombus
- •left atrial size >65 mm
- •left ventricular ejection fraction <35%
结局指标
主要结局
freedom from any atrial arrhythmia
时间窗: 12 months
次要结局
- rate of significant adverse events (SAEs)(12 months)
- atrial fibrillation burden by ILR(12 months)
研究者
研究点 (2)
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