NCT02002923Unknown2 期
Pulmonary Vein Isolation Versus Botulinum Toxin Injection Plus Pulmonary Vein Isolation in Patients With Atrial Fibrillation
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Freedom of AF or other atrial arrhythmias
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 treatment strategies, PVI only versus PVI plus BT injection, in patients with persistent and paroxysmal AF. Results were assessed after follow-up of at least 1 years 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 paroxysmal 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 only
Active Comparator
干预措施: Pulmonary vein isolation (Procedure)
PVI+BT injection
Active Comparator
干预措施: Pulmonary vein isolation (Procedure)
PVI+BT injection
Active Comparator
干预措施: Botulinum Toxin (Drug)
结局指标
主要结局
Freedom of AF or other atrial arrhythmias
时间窗: 1 year
次要结局
- serious adverse events(1 year)
研究者
研究点 (1)
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