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
- 2
- 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
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