Botulinum Toxin Injection for Preventing Secondary Atrial Fibrillation in Patient With Supra-ventricular Tachyarrythmias
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- number of episodes of atrial fibrillation
研究概览
简要总结
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, RFA versus RFA plus botulinum toxin injection, in patients with supra-ventricular tachyarrhythmias. Results were assessed with the use of an implanted monitoring device (IMD).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •atrial flutter, AV nodal re-entry tachycardia, focal atrial tachycardia, WPW syndrome
- •secondary atrial fibrillation
排除标准
- •congestive heart failure
- •LV ejection fraction < 35%
- •left atrial diameter > 60 mm
研究组 & 干预措施
RFA
Mapping and radiofrequency ablation are performed by using standard methods.
干预措施: radiofrequency ablation (Procedure)
RFA+BT injection
Mapping and radiofrequency ablation are performed by using standard methods.
Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
干预措施: radiofrequency ablation (Procedure)
RFA+BT injection
Mapping and radiofrequency ablation are performed by using standard methods.
Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
干预措施: botulinum toxin injection (Drug)
结局指标
主要结局
number of episodes of atrial fibrillation
时间窗: 1 year
次要结局
- serious adverse events(1 year)