Randomized Comparison of Catheter Ablation Versus Anti-arrhythmic Drug Therapy in Patients With Recently Diagnosed Paroxysmal Atrial Fibrillation as Assessed by a Continuous Implantable Monitor
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percentage of AF burden
研究概览
简要总结
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.
详细描述
Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy
排除标准
- •Previous treatment with Class IC or class III AAD
- •Previous AF ablation procedure
- •Congestive heart failure (NYHA III-IV functional class)
- •Left Ventricle ejection fraction less than 35%
- •Left atrial diameter > 55mm
- •Unwillingness to participate
研究组 & 干预措施
Antiarrhythmic drug
Class I or III antiarrhythmic drug
干预措施: Antiarrhythmic drug (Drug)
Catheter ablation
Pulmonary vein isolation
干预措施: Catheter ablation (Procedure)
结局指标
主要结局
Percentage of AF burden
时间窗: 4 months
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
次要结局
- All-death death(4 months)
研究者
Jonathan Steinberg,MD
Director Arrhythmia Services, Valley Health System
Valley Health System