Catheter Ablation in Congenital Heart Disease: French National Prospective Registry
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence of targeted arrhythmia
研究概览
简要总结
Arrhythmias represent one of the main late complications in patients with congenital heart disease. Atrial arrhythmias are associated with a significant morbidity and are the first cause of urgent hospitalization, and sudden death from ventricular arrhythmias is a leading cause of death in this population.
The exponential increase of the number of patients with congenital heart disease and the improvement of ablative technologies are associated with a significant increase of the number of catheter ablation procedures.
Most of available studies are retrospective or include a limited number of patients.
The aim of this study is to assess the efficacy of catheter ablation in patients with congenital heart disease through a national prospective registry. Secondary objectives are i) to identify factors associated with catheter ablation efficacy in different cardiac defects, ii) to describe complications associated with catheter ablation in this specific population, and iii) to assess the impact of catheter ablation on quality of life of patients with congenital heart disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with congenital heart disease referred for catheter ablation
排除标准
- •Absence of patient's consent
- •Patient under guardianship or curatorship
- •Pregnant woman
结局指标
主要结局
Recurrence of targeted arrhythmia
时间窗: 12 months
Rate of freedom from targeted arrhythmia recurrence
次要结局
- Quality of life assessed by EQ5D3L score(6 months)
- Recurrence of any arrhythmia(12 months)
- Long-term recurrence of targeted and any arrhythmia(24 months)
- Complications(1 month)
- Quality of life assessed by SF36 score(6 months)