NCT00477230终止3 期
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic Atrial Fibrillation (AF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- CardioFocus
- 入组人数
- 64
- 试验地点
- 18
- 主要终点
- Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
研究概览
简要总结
The purpose of the study is to compare two types of treatment for atrial fibrillation (AF) that are designed to treat the symptoms of atrial fibrillation. The treatments being compared are:
- A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
- Standard drug therapy (antiarrhythmic drugs)
To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.
Eligibility Criteria
Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:
- 18 to 80 years of age
- Frequent episodes of AF
- Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
- Other criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •18 to 80 years old
- •Paroxysmal atrial fibrillation (AF)
- •Frequent episodes of AF
- •Failed at least 1 drug treatment
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Single ablation procedure with Endoscopic Ablation System
干预措施: Endoscopic Ablation System (Device)
2
Active Comparator
Medication
干预措施: Standard Anti-arrhythmic Drug (AAD) Therapy (Drug)
结局指标
主要结局
Freedom for Symptomatic Episode of Atrial Fibrillation at One Year
时间窗: One Year
次要结局
未报告次要终点
研究者
研究点 (18)
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