Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Recurrence of any sustained arrhythmia (>30 sec.)
研究概览
简要总结
Ablation of consecutive atrial tachycardia (AT) after ablation of atrial fibrillation (AF) or cardiac surgery can be challenging due to complex substrate and AT mechanisms. A substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. With the availability of novel ultra-high-density mapping techniques characterization and understanding of AT mechanisms and underlying substrate can be improved. Aim of this prospective, multi-center, randomized study is to compare a standard AT ablation approach versus minimalized ablation of the clinical AT in regards to arrhythmia free survival.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive AT subsequent to prior AF ablation procedure or cardiac surgery
- •Surface ECG-documentation of AT as primary clinical arrhythmia
- •ECG indicating stable, map-able AT (stable activation sequence, and CL stability) with cycle length ≥ 200ms
排除标准
- •< 18 years
- •No previous atrial fibrillation ablation procedure or cardiac surgery
- •Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment
- •History of hemorrhagic diathesis or other coagulopathies
- •Contraindications for oral anticoagulation
- •Hyper- or hypothyroidism
- •Has any condition that would make participation not be in the best interest of the subject
结局指标
主要结局
Recurrence of any sustained arrhythmia (>30 sec.)
时间窗: 1 year
次要结局
- Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success)(Intraprocedural)
- Area of low voltage in sinus map (cm2)(Intraprocedural)
- Total radiofrequency application time(intraprocedural)
- Fluoroscopy time(intraprocedural)
- Number of blocked lines(intraprocedural)
- Predictability of secondary AT by analysis of clinical AT map and voltage map(Intraprocedural)
- Procedure duration time(Intraprocedural)
- Ablated area (cm2)(intraprocedural)
研究者
Christian Meyer
Prof. Dr. Christian Meyer
Evangelical Hospital Düsseldorf