European Pediatric Catheter Ablation Registry
试验速览
- 阶段
- 不适用
- 发起方
- 试验地点
- 6
- 主要终点
- To collect data on ablation procedures in the European pediatric population.
研究概览
简要总结
The main objective of the European Pediatric Catheter Ablation Registry is to collect data on ablation procedures in the European pediatric population in order to improve the management of this subset of patients.
详细描述
Catheter ablation has revolutionized the management of cardiac arrhythmias in patients and has become first-line therapy for managing many pediatric patients with atrioventricular accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia.
Cardiac ablation in children is not a standardized procedure as in adults as evidence gaps still have to be filled. On a European perspective, lack of a dedicated scientific society has limited so far the collection and sharing of data among the most experienced centers.
Actually there are no sufficient data available about the management of pediatric patients undergoing ablation in clinical practice, in particular regarding indications, methodology and clinical follow-up.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients scheduled to any kind of an ablation procedure;
- •Patient´s age between 0 and 18 years;
- •Legal guardians understand the nature of the procedure, are willing to comply with study follow-up evaluations, and provide written informed consent prior to the procedure.
排除标准
- •Patient unable to comply with follow-up schedule;
- •Patient has medical conditions that preclude protocol compliance or limit study participation;
- •Legal guardian or patient unwilling or unable to provide informed consent.
结局指标
主要结局
To collect data on ablation procedures in the European pediatric population.
时间窗: After 12 months from the ablation procedure
Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)
次要结局
- To describe and compare different ablation methodologies(After 12 months from the ablation procedure)
研究者
Paolo De Filippo
Principal Investigator
A.O. Ospedale Papa Giovanni XXIII