Radiofrequency Ablation of Symptomatic Frequent Ventricular Premature Complexes as a First-line Therapy in Pediatric Population Without Structural Heart Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
研究概览
简要总结
To evaluate the effectiveness and safety of catheter ablation of frequent symptomatic PVCs in the pediatric population as first-line therapy compared with antiarrhythmic drugs.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic, frequent, premature ventricular complexes (more than 10,000 according to the 24 hour Holter ECG)
排除标准
- •Antiarrhythmic therapy before inclusion Structural heart pathology requiring surgical correction; Premature ventricular complexes associated with structural heart disease; Previously performed radiofrequency ablation due to premature ventricular complexes.
研究组 & 干预措施
Ablation
Standard radiosurgery ablation of premature ventricular complexes using navigation system.
干预措施: Radiofrequency catheter ablation (Procedure)
Ablation
Standard radiosurgery ablation of premature ventricular complexes using navigation system.
干预措施: NAVI-STAR® RMT ThermoCool (Device)
Control
Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
干预措施: Metoprolol (Drug)
Control
Antiarrhythmic therapy of premature ventricular complexes according to the guidlines
干预措施: Verapamil (Drug)
结局指标
主要结局
The presence of premature ventricular complexes ≥ 300 according to the 24-hour Holter ECG monitoring
时间窗: 12 months
次要结局
- Complications(12 months)
- Left ventricle diameter(12 months)
- Premature ventricular complexes burden according to the 24- hour Holter ECG(12 months)
- Right ventricle diameter(12 months)
- Ventricular tachycardia according to the 24- hour Holter ECG(12 months)