Adenosine Effect on Persistent Pulmonary Vein Isolation Line Evaluation (APPLE Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
研究概览
简要总结
The investigators studied the effects of adenosine on the reconnection rate after successful pulmonary veins isolation by radiofrequency catheter ablation in patients with drug-resistant atrial fibrillation
详细描述
Pulmonary vein isolation has emerged as an effective therapy for paroxysmal atrial fibrillation. However, atrial fibrillation recurs in up to 50% of patients, generally because of recovery of pulmonary vein conduction.
Adenosine given during the initial procedure may reveal dormant pulmonary vein conduction, thereby identifying the need for additional ablation, leading to improved outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed atrial fibrillation
- •recurrence of symptomatic atrial fibrillation in spite of Antiarrhythmic drug use
- •written informed consent
排除标准
- •intracardiac thrombus
- •pregnancy
研究组 & 干预措施
adenosine arm
single arm study
干预措施: Adenosine arm (Drug)
结局指标
主要结局
Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion
时间窗: 5 minutes after IV adenosine
After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
次要结局
- Atrial Fibrillation Recurrence(between 0 and 12 months)
研究者
Yong Seog Oh
MD
Seoul St. Mary's Hospital