Comparison of Efficacy Between Impedance Guided and Contact Force Guided Atrial Fibrillation Ablation Using Automated Annotation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
研究概览
简要总结
The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system (Visitag™). Patients who receive atrial fibrillation ablation are randomly assigned in the same number to two groups with impedance guided ablation and contact force guided ablation using contact force sensing catheter (THERMOCOOL® SMARTTOUCH™ catheter, Biosense Webster, Inc., Diamond Bar, CA).
详细描述
During atrial fibrillation ablation, the location where ablation is conducted is displayed through annotation tags using 3D system to recognize energy delivery is done at the area. However this annotation method was unable to identify how effectively the ablation is done. To remedy this disadvantage, automated annotation system (VisiTag™ module, Biosense Webster, Inc., Diamond Bar, CA) was recently developed to make an automatic annotation when all pre-defined criteria are satisfied. But study on the clinical effects of this system is insufficient.
The purpose of this study is to compare the efficacy of catheter ablation for atrial fibrillation between contact force-guided and impedance-guided annotation using automated annotation system.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with non-valvular atrial fibrillation
- •Patients having atrial fibrillation even after receiving continued treatment with at least 1 antiarrhythmic drug for more than 6 weeks
- •Patients with tachycardia-bradycardia syndrome associated with atrial fibrillation.
- •Patients who can understand the information sheet and consent form on the need and procedure of catheter ablation and submitted them
- •Patients who are available of follow-up at least for more than three months after catheter ablation
排除标准
- •Patients unsuitable for catheter ablation because the size of left atrium is over 5.5cm
- •Patients unsuitable for catheter ablation due to previous history of pulmonary surgery or structural heat disease.
- •Patients who cannot receive standard treatments such as anticoagulation therapy which need to be continuously performed prior to radiofrequency catheter ablation
- •Patients in the subject group vulnerable to clinical study
- •Patients who had undergone a prior catheter ablation for atrial fibrillation
研究组 & 干预措施
Impedance Guided Ablation Group
Impedance guided ablation group performs pulmonary vein(PV) isolation guided by annotation criteria with minimum time of 10 seconds, maximum range of 2 mm, and minimum impedance decrease over 5 Ohms instead of CF parameters. In the impedance guided group, operators are blinded to contact force data during PV isolation.
干预措施: Ablation (Device)
Contact Forced Guided Ablation Group
Contact force(CF) guided ablation group performs pulmonary vein (PV) isolation guided by automated annotation criteria with minimum time of 10 seconds, maximum range of 2mm, CF over time of 50% and minimum CF of 10 g.
干预措施: Ablation (Device)
结局指标
主要结局
Acute success rate of pulmonary vein isolation obtained after initial circumferential ablation line around pulmonary veins
时间窗: 6 hours
Acute success is defined as confirmation of entrance block in all pulmonary veins
次要结局
- Recurrence of any atrial arrhythmias (atrial fibrillation or atrial tachycardia)(12 months)
- Procedure time(6 hours)
- Ablation time(6 hours)
- Average contact force of each ablation lesion(6 hours)
- Impedance drop of each ablation lesion(6 hours)
- Force time integral of each ablation lesion(6 hours)