Multi-center, Controlled Trial to Compare the Feasibility, Safety and Efficacy of Zero-fluoroscopic Approach With Fluoroscopic Approach for the Ablation of Paroxysmal Supraventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,060
- 试验地点
- 1
- 主要终点
- Procedural success rate
研究概览
简要总结
This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
详细描述
Fluoroscopy is the imagine modality routinely used in catheter ablation of cardiac arrhythmias. As we all know,fluoroscopic radiation is harmful both to the patients and the operation staffs. Recently,three-dimensional navigation systems have been developed and implemented in electrophysiological procedures for guiding catheters inside the heart chambers. Among the three-dimensional navigation systems, Ensite NavX is a promising system used for zero-fluoroscopic approach for performing catheter ablation of paroxysmal supraventricular tachycardia. This study is aimed to compare the feasibility, safety and efficacy of a zero-fluoroscopic approach using Ensite NavX with conventional fluoroscopic approach using Ensite NavX plus fluoroscopy for the ablation of paroxysmal supraventricular tachycardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrioventricular Nodal Reentrant Tachycardia
- •Atrioventricular Reentrant Tachycardia
排除标准
- •Atrial Tachycardia
- •Organic supraventricular tachycardia
结局指标
主要结局
Procedural success rate
时间窗: one year
Procedural success for AVNRT was defined as the absence of inducible tachycardia either under basal condition or under isoproterenol stimulation. Procedural success for AVRT was defined as the non-inducibility of tachycardia, loss of pre-excitation (if manifest), loss of retrograde accessory pathway conduction and transient atrioventricular block induced by intravenous adenosine.
次要结局
- Complications(one year)
- Immediate success rate(one day)
- Recurrence Rate(1 year)
- Total procedure time(one day)
- Fluoroscopy time(one day)