NCT03053570Unknown不适用
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)
China Cardiometabolic Registries1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of participants with successful Pulmonary Vein Isolation
研究概览
简要总结
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.
详细描述
The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.
排除标准
- •Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.
结局指标
主要结局
Number of participants with successful Pulmonary Vein Isolation
时间窗: in one year
次要结局
未报告次要终点
研究者
研究点 (1)
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