NCT00540787已完成4 期
A Randomized Comparison of the Efficacy of Antiarrhythmic Drug Therapy and Radiofrequency Catheter Ablation for the Maintenance of Sinus Rhythm In Patients With Paroxysmal Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 6
- 主要终点
- Recurrence of Atrial Fibrillation
研究概览
简要总结
The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •18 years of age or older
- •Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
- •Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
- •Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor
排除标准
- •Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
- •History of any previous ablation for atrial fibrillation
- •Intracardiac thrombus
- •Atrial fibrillation due to reversible cause
- •Pregnancy
- •Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)
研究组 & 干预措施
Drug Treatment
Active Comparator
干预措施: Radiofrequency ablation, antiarrhythmic drugs (Device)
Drug Treatment
Active Comparator
干预措施: Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs (Drug)
ThermoCool Radiofrequency Catheter
Active Comparator
Radiofrequency catheter used.
干预措施: Radiofrequency ablation, antiarrhythmic drugs (Device)
ThermoCool Radiofrequency Catheter
Active Comparator
Radiofrequency catheter used.
干预措施: ThermoCool Radiofrequency Catheter (Device)
结局指标
主要结局
Recurrence of Atrial Fibrillation
时间窗: One year
To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year.
次要结局
- Efficacy of ablation and drug treatment(One year)
研究者
研究点 (6)
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