NCT02984371Unknown2 期
Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting
Meshalkin Research Institute of Pathology of Circulation3 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 264
- 试验地点
- 3
- 主要终点
- Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
研究概览
简要总结
The aim of this prospective randomized study was to assess the efficacy of ablation of the ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years, with 2 documented episodes over the last 6 months)
- •Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery
排除标准
- •Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned maze procedure or pulmonary vein isolation Unwillingness to participate
结局指标
主要结局
Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
时间窗: 12 month
次要结局
- stroke or transient ischemic attack(12 month)
- atrial fibrillation burden(12 month)
- incidence of congestive heart failure(12 month)
- incidence of sustained ventricular arrhythmias(12 month)
- rehospitalization(12 month)
- number of Deaths(12 month)
研究者
研究点 (3)
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