A Prospective Registry of Atrial Fibrillation Ablation Using the Prediction of Lesion Depth Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Freedom from atrial fibrillation
研究概览
简要总结
This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology.
详细描述
This is an observational multicenter registry of atrial fibrillation catheter ablation performed using the ablation index technology, which has been introduced as a tool predicting ablation lesion depth. The index incorporates the following characteristics of radiofrequency point-by-point ablation: radiofrequency energy power, contact force, duration of ablation. Since the ablation index is calculated for every individual operator depending on his(her) personal skills, there is no a strict indication on the safe and effective range of the index. This registry aims to evaluate ablation index values used in different centers by different operators. Prospective information on arrhythmia recurrence rate and type, characteristics of redo ablations, characteristics of reconduction ablated areas will be gathered.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indications for catheter ablation of atrial fibrillation;
- •signed informed consent
排除标准
- •Presence of contraindications to AF ablation
结局指标
主要结局
Freedom from atrial fibrillation
时间窗: 1 year
Number of participants with no evidence of atrial tachyarrhythmia longer than 30 s in duration at 12 months after ablation, as detected by regular ECG monitoring according to centres' established practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening). Data will be collected using a web-based system with electronic case report forms.
次要结局
- Fluoroscopy time(24 hours)
- Acute complications(30 days)
- Procedure time(180 minutes)
- Electrical reconduction(2 years)