NCT03044925Unknown不适用
Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Clinical efficacy (time to first AF recurrence after blanking period)
研究概览
简要总结
Compare the safety and efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
详细描述
- Compare the efficacy of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
- Compare the safety of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
- Compare the procedural parameters of remote magnetic navigation-guided ablation and cryoablation for patients with persistent atrial fibrillation.
- Compare the effects of amiodarone on recurrence after these two different ablation procedures.
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
- Single (Participant)
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 (>7d, < 5years)
- •Age 18-75 years
- •Patient is mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol
排除标准
- •Any previous left atrial ablation or surgery
- •Any cardiac surgery or percutaneous coronary intervention within 3 months prior to enrollment
- •Stroke or transient ischemic attack within 6 months prior to enrollment
- •Myocardial infarction within 3 months prior to enrollment
- •Anteroposterior left atrial diameter > 55 mm
研究组 & 干预措施
Remote magnetic navigation
Experimental
Persistent atrial fibrillation ablation with remote magnetic navigation
干预措施: Remote magnetic navigation (Procedure)
Cryoablation
Active Comparator
Persistent atrial fibrillation ablation with cryoballoon
干预措施: Cryoablation (Procedure)
结局指标
主要结局
Clinical efficacy (time to first AF recurrence after blanking period)
时间窗: one year
the time to first AF recurrence after blanking period (month)
Clinical safety (Any procedure-related complications)
时间窗: one year
Any procedure-related complications
次要结局
- Procedure time (min)(one week)
- Time to first cardiovascular hospitalization (month)(one year)
- QoL of 12 months (Units on a Scale)(one year)
- X-ray time (min)(one week)
研究者
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