NCT00982475已完成不适用
Ablation at St. George Hospital - Prospective Randomized Comparison of Manual and Mechanical Remote Robotic Catheter Ablation for Drug-Refractory Atrial Fibrillation
Dr. Kai Jaquet2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2009年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Freedom of AF 12 months after procedure.
研究概览
简要总结
Long term results after pulmonary vein isolation (PVI) with robotic navigation in patients with drug refractory atrial fibrillation are not inferior to manual radiofrequency current ablation.
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •paroxysmal atrial fibrillation
- •persistent atrial fibrillation < 2 month
- •indication for catheter ablation
- •LEF > 50%
- •diameter LA < 50 mm
排除标准
- •intracardial thrombus
- •atrial fibrillation with underlying curable disease
- •renal failure > stage I
- •contraindication for anticoagulation
- •life expectancy < 12 month
- •previous PVI
- •pregnancy
研究组 & 干预措施
PVI with robotic navigation
Active Comparator
干预措施: Pulmonary vein isolation with radiofrequency current (Procedure)
PVI manually
Placebo Comparator
干预措施: Pulmonary vein isolation with radiofrequency current (Procedure)
结局指标
主要结局
Freedom of AF 12 months after procedure.
时间窗: 12 month
次要结局
未报告次要终点
研究者
Dr. Kai Jaquet
Prof. Dr. Roland Richard Tilz
Asklepios proresearch
研究点 (2)
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