A Clinical Study to Evaluate the Safety and Efficacy of the CryoCor(TM)Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 24
- 主要终点
- Safety profile of intervention
研究概览
简要总结
A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
详细描述
The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.
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
- 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
- •At least 3 episodes of PAF within 6 months
- •Refractory to at least one drug
- •Therapeutic anticoagulation
- •Signed informed consent
排除标准
- •Persistent AF
- •Structural heart disease
- •Prior ablation
- •Contraindication present
研究组 & 干预措施
Treatment with CryoCor Cryoablation System
Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
干预措施: Cardiac CryoCor Cryoablation System (Device)
Treatment with standard medical therapy
Intervention includes treatment with ant-arrhythmic medications alone.
干预措施: Medical management (Drug)
结局指标
主要结局
Safety profile of intervention
时间窗: 12 months
Recurrence of PAF
时间窗: 12 months
次要结局
- Change in QOL as measured by Symptom Checklist(12 months)
- Change in QOL as measured by SF-36 Health Survey(12 months)
- Change in QOL as measured by Arrhythmia Severity scale(12 months)
- Change in luminal PV measurements(6 months)
- Time to treatment failure, post resolution period(Post resolution period (12 months follow-up))