NCT00113178已完成3 期
Clinical Study to Evaluate the Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Cavo-Tricuspid Valve Isthmus-Dependent Atrial Flutter
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Acute efficacy
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.
详细描述
Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic atrial flutter
排除标准
- •Prior ablation
- •Contraindication to intervention
- •Poor general health
结局指标
主要结局
Acute efficacy
Acute safety
次要结局
- Long-term efficacy
- Long-term safety
研究者
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