French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Ventricular arrhythmias
研究概览
简要总结
National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.
详细描述
Inclusion criteria:
- patient with tetralogy of Fallot > 18 years
- implantable cardioverter defibrillator (ICD)
- primary or secondary prevention
All french centers performing ICD implantation are annually contacted to include all patients with tetralogy of Fallot and ICD.
Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with prospective follow up and annual update.
All events are centrally adjudicated with collection of all baseline ECG and reviewing of endocavitary EGM.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tetralogy of Fallot
- •implantable cardioverter defibrillator
排除标准
- •age < 18 years
结局指标
主要结局
Ventricular arrhythmias
时间窗: through study completion, an average of 1 year
Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation
Complications of ICD
时间窗: through study completion, an average of 1 year
Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction
次要结局
未报告次要终点
研究者
Marijon
Principal Investigator Dr Victor WALDMANN
Paris Sudden Death Expertise Center