Safety and Efficacy of Intracardiac Echocardiography-guided Zero-fluoroscopic Cryoballoon Ablation for Atrial Fibrillation : A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Radiation exposure time
研究概览
简要总结
This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.
详细描述
Patients (n=100) undergoing de novo CBA for paroxysmal AF were randomly assigned (1:1) to zero-fluoroscopic (Zero-X) and conventional fluoroscopy groups.
Radiation exposure, procedural time, acute and long term outcome were analyzed.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation
排除标准
- •age < 18 years
- •history of AF ablation or cardiac surgery
- •contraindication to oral anticoagulants
- •presence of intracardiac thrombus or significant coronary artery disease on cardiac computed tomography prior to the procedure.
结局指标
主要结局
Radiation exposure time
时间窗: 1 day
comparison of radiation exposure time between the two groups
Radiation exposure dose
时间窗: 1 day
comparison of radiation exposure dose between the two groups
Recurrence rate of atrial tachyarrhythmias
时间窗: 3 months
long term outcome : Recurrence rate of atrial tachyarrhythmias 3 months after the procedure
acute success rate
时间窗: 1 day
successful rate of pulmonary vein isolation
次要结局
- Procedure time(1 day)