Endomyocardial Botulinum Toxin Injection in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
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, PVI plus linear lesions (LL) plus botulinum toxin injection versus PVI plus linear lesions (LL), in patients with persistent or longstanding persistent AF. 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
- •Persistent and longstanding persistent AF
排除标准
- •congestive heart failure
- •LV ejection fraction < 35%
- •left atrial diameter > 60 mm
研究组 & 干预措施
PVI+LL
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
干预措施: Pulmonary vein isolation (Procedure)
PVI+LL
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
干预措施: Linear Lesion Ablation (Procedure)
PVI+LL+BT injection
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
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: Pulmonary vein isolation (Procedure)
PVI+LL+BT injection
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
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: Linear Lesion Ablation (Procedure)
PVI+LL+BT injection
Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
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: BT injection (Drug)
结局指标
主要结局
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
时间窗: 1 year
次要结局
- serious adverse events(1 year)