Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Efficacy endpoint (time to first documented clinical recurrence after blanking period)
研究概览
简要总结
It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.
详细描述
The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.
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
- •ECG recording of atrial fibrillation
- •first time of ablation
- •refractory to at least one anti-arrhythmia drug
- •sign informed consent for participation in the study
排除标准
- •had ablation before
- •serious heart failure
- •left atrial diameter>55mm
- •Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
- •Stroke in 6 months before the ablation
- •Endocardial thrombosis
研究组 & 干预措施
cryoballoon ablation
patients who accept cryoballoon ablation
干预措施: cryoballoon ablation (Procedure)
radiofrequency ablation
patients who accept radiofrequency ablation
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
Efficacy endpoint (time to first documented clinical recurrence after blanking period)
时间窗: one year
the time to first documented clinical recurrence after blanking period (month)
Safety endpoint (Any procedure-related complications)
时间窗: one year
Any procedure-related complications
次要结局
- QoL changes at 12 months (Units on a Scale)(one year)
- X-ray time (min)(one year)
- Procedure time (min)(one year)
- Left atrial time (min)(one year)
- time to first time cardiovascular hospitalization (month)(one year)