Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Ablation time
研究概览
简要总结
The investigators will compare the ablation time during pulmonary vein isolation of Ablation Index-guided high power ablation with those with conventional ablation.
Ablation time of conventional group will be used from OPTIMUM study. For secondary outcomes, acute outcomes of pulmonary vein isolation using two different strategies will be compared. During 1 year of follow-up in both groups, atrial fibrillation recurrence will be evaluated. The atrial fibrillation recurrence rate at 1 year after pulmonary vein isolation will be compared between the two groups. In addition, fluoroscopic time, procedure time, and complication rates for the high power ablation group will be compared with those with conventional power.
详细描述
Ablation Index guided high power ablation will be performed in 70 patients with atrial fibrillation with prospectively and consecutively. A contact force-sensing catheter will be used. Ablation will be performed with point-by-point technique using Visitag automated annotation criteria as below;
Ablation Index(AI) target:
- Anterior/roof : 450 AI
- Anterior near carina area : 500 AI
- Posterior/inferior/carina : 350 AI
- Posterior near carina area : 400 AI
- Area near esophagus :25W, 15sec or 300 AI (no further ablation if esophageal temperature increase more than 39°C)
- Interlesion distance ≤ 4.5mm
VISITAGTM settings
- 2.5mm stability range
- 7 sec stability time
- FOT 25%, 3g force
- Tag size 2mm
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 symptomatic paroxysmal or persistent AF who failed anti-arrhythmic agents
排除标准
- •Patients who had previous ablation for AF
- •Patients with left atrial diameter more than 50 mm
- •Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist (VKA) or non-VKA (NOAC) agent
- •Known severe left ventricular systolic dysfunction (ejection fraction <35%)
- •Pregnancy
结局指标
主要结局
Ablation time
时间窗: during procedure
To compare ablation time of ablation index guided high power ablation for pulmonary vein isolation in patients with atrial fibrillation
次要结局
- Total time(during procedure)
- residual potential after first pass pulmonary vein encirclement(during procedure)
- acute pulmonary vein reconnection(1 year)
- any atrial fibrillation/atrial tachycardia recurrence(1-year after index procedure)
- Rate of Complication(1 year)