Comparison of Acute Pulmonary Vein (PV) Reconnection Between Contact Force Guided and Blinded PV Isolation in Patients With Symptomatic Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of immediate PV isolation ratio after final ablation according to contact force-guided ablation, change of impedance, total ablation time, and procedure time according to contact force-guided strategy
研究概览
简要总结
Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing catheter is a new catheter which has valuable tools to monitor and increase the efficacy of PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on immediate PV isolation and outcome. However, there might be confounding factor as inter-individual variation. Therefore, we would like to compare the efficacy of contact force-sensing catheter within same patient but different veins.
In this study, we would like to confirm the efficacy of contact force-sensing catheter on immediate PV isolation outcome within same patient. This study randomized the right or left PVs whether to use the contact force-sensing function or not. The study design will minimize the inter-individual variation on evaluating the efficacy of contact force-sensing catheter on immediate PV isolation.
Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy of contact force-sensing catheter on PV isolation.
详细描述
Sixty patients will be randomized to select right or left pulmonary veins whether to apply contact force-guided ablation or contact force-blinded ablation strategy. Each PV will be ablated with same contact force-sensing catheter (Thermocool Smart Touch Catheter, Biosense Webster Inc. CA). The PV (right or left) which will be randomized to contact force-sensing PV or blind PV. Contact force-sensing PV will be ablated guided by contact force, whereas the blind PVs will be ablated without contact force-sensing information. The change of impedance, total ablation and time to ablate PV will be collected and analysed according to contact force-sensing strategy. After exit and entrance block by conventional method, dormant conduction will be evaluated by using adenosine. The proportion of dormant conduction will be compared between contact force-sensing guided or blinded strategy.
During 1-year follow up, patients who recurred AF or AT will be undergo second ablation procedure. In these patients, PV reconnection rate will be evaluated by a duodecapolar lasso circular mapping catheter. We would like to know whether PVs which have ablated with contact force-sensing information at index procedure have less reconnection than those which was ablated without contact force-sensing information.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with symptomatic paroxysmal atrial fibrillation (AF) who had failed with anti-arrhythmic agents.
排除标准
- •Patients who had previous ablation for AF
- •Patients with symptomatic persistent AF
研究组 & 干预措施
Lt PV CF guided/rt PV CF blinded
Fifteen patients will be allocated to this group. Left side pulmonary veins isolation will be performed with contact force information guidance. Then, right side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).
干预措施: SmartTouch Catheter (Device)
Lt PV CF blinded/rt PV CF guided
Fifteen patients will be allocated to this group. Left side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).Then, right side pulmonary veins isolation will be performed with contact force information guidance.
干预措施: SmartTouch Catheter (Device)
Rt PV CF guided/lt PV CF blinded
Fifteen patients will be allocated to this group. Right side pulmonary veins isolation will be performed with contact force information guidance. Then, left side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).
干预措施: SmartTouch Catheter (Device)
Rt PV CF blinded/lt PV CF guided
Fifteen patients will be allocated to this group. Right side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter). Then, left side pulmonary veins isolation will be performed with contact force information guidance.
干预措施: SmartTouch Catheter (Device)
结局指标
主要结局
Proportion of immediate PV isolation ratio after final ablation according to contact force-guided ablation, change of impedance, total ablation time, and procedure time according to contact force-guided strategy
时间窗: Immediate after PV isolation (acute result)
次要结局
- Proportion of PV reconnection according to contact force-guided ablation in patients with AF recurrence(1 year)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital