NCT02814136Unknown不适用
Comparison of Wide Area Circular Ablation With Extra-wide Area Circular Ablation in Subjects With Persistent Atrial Fibrillation, a Randomized Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.
研究概览
简要总结
Ablation of atrial fibrillation is an established method for treatment of subjects with atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide area circular ablation (WACA) is shown to provide the same results with fewer complications. This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects who are considered for ablation of atrial fibrillation.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects with symptomatic persistent atrial fibrillation who are scheduled for clinically indicated ablation of AF.
排除标准
- •Subjects younger than 18 year of age.
- •Subjects who are pregnant.
- •Subjects who are unable to provide consent.
研究组 & 干预措施
WACA
Active Comparator
wide area circular ablation
干预措施: Ablation (Procedure)
EWACA
Active Comparator
extra-wide area circular ablation
干预措施: Ablation (Procedure)
结局指标
主要结局
To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.
时间窗: 1 year
次要结局
- ii. To compare the time to reoccurrence of atrial fibrillation, atrial flutter and/or atrial tachycardia in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.(1 year)
研究者
Mazda Biria
Principle Investigator
Mosaic Life Care
研究点 (2)
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