NCT02003001Unknown1 期
Endomyocardial Botulinum Toxin Injection Can Prevent Ventricular Arrhythmias: Pilot Study
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- freedom of ventricular arrhythmias
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 left ventricle for preventing ventricular arrhythmias.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •symptomatic ventricular arrhythmias
- •drug-resistance
- •unsuccessful one or more ablation procedure with future unreasonable tries
排除标准
- •Previous heart surgery and AF ablation procedure
- •Emergency CABG
- •Unstable angina or heart failure
- •Use 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%
- •Unwillingness to participate
研究组 & 干预措施
BT injection
Experimental
干预措施: Botulinum Toxin (Drug)
结局指标
主要结局
freedom of ventricular arrhythmias
时间窗: 1 year
次要结局
- serious adverse events(1 year)
- time to recurrence of ventricular arrhythmias(1 year)
研究者
研究点 (1)
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