NCT01863472已完成不适用
Catheter Ablation of Drug-refractory Persistent Atrial Fibrillation With the HeartLight(TM) Laser Balloon in Comparison With Irrigated Radiofrequency Current Ablation
Boris Schmidt12 个研究点 分布在 3 个国家目标入组 152 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 12
- 主要终点
- Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
研究概览
简要总结
Aim of the study is to compare the safety and efficacy of pulmonary vein isolation using the endoscopic ablation system in comparison to irrigated radiofrequency current ablation in patients with drug-refractory persistent 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years
- •persistent atrial fibrillation
- •failure of at least one antiarrhythmic drug
排除标准
- •contraindications for pulmonary vein isolation (PVI)
- •previous PVI attempts
- •inability to be treated with oral anticoagulation
- •presence of intracardiac thrombi
- •pregnancy
结局指标
主要结局
Documented recurrence of atrial fibrillation or any atrial tachyarrhythmia >30 seconds
时间窗: between day 90 and 365 days after index procedure
次要结局
未报告次要终点
研究者
Boris Schmidt
Arzt für Kardiologie
Cardioangiologisches Centrum Bethanien
研究点 (12)
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