NCT01842529已完成2 期
Botulinum Toxin Injection in Epicardial Fat Pads Can Prevent Recurrences of Atrial Fibrillation After Cardiac Surgery: Randomized Pilot Study
Meshalkin Research Institute of Pathology of Circulation4 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug
研究概览
简要总结
The aim of this prospective randomized double-blind study was to compare the efficacy and safety of Botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass graft (CABG) surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for CABG according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for CABG surgery
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
recurrence of > 30 secs of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia, after CABG procedure on no antiarrhythmic drug
时间窗: 1 year
次要结局
- time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU(1 year)
- post-CABG length of stay(1 year)
- incidence of congestive heart failure(12 months)
- incidence of sustained ventricular arrhythmias(12 months)
- incidence of myocardial infarction(12 months)
- incidence of renal failure(12 months)
- incidence of respiratory failure(12 months)
- stroke or transient ischemic attack(12 months)
- rehospitalization(12 months)
- readmission to ICU(12 months)
- number of deaths(12 months)
研究者
研究点 (4)
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