NCT02002988Unknown1 期
Endomyocardial Botulinum Toxin Injection Can Prevent Drug-Resistant Paroxysmal Atrial Fibrillation: Pilot Study
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- serious adverse events
研究概览
简要总结
The aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •drug-resistant PAF
排除标准
- •Previous heart surgery and AF ablation procedure
- •Emergency CABG
- •Unstable angina or heart failure
- •Persistent AF, AF at the time of screening (planned Maze procedure or pulmonary vein isolation)
- •Use of I or III antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone)
- •Requiring concomitant valve surgery
- •Left ventricle ejection fraction <35%
- •Left atrial diameter >55 mm
- •Unwillingness to participate
结局指标
主要结局
serious adverse events
时间窗: 1 year
次要结局
- number of paroxysms(1 year)
研究者
研究点 (2)
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