PRospEctiVE Study on implaNTable cardIOverter Defibrillator Therapy and SuddeN Cardiac Death in Adults With Congenital Heart Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 783
- 主要终点
- Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia
研究概览
简要总结
Sudden cardiac death (SCD) is one of the major causes of mortality in adults with congenital heart disease (ACHD). Risk stratification for sudden cardiac death in this patient group is challenging and at the current moment there are no clear guidelines on implantable cardioverter-defibrillator (ICD) implantation for primary prevention of SCD in this young patient population. The reason for this is the fact that this is a heterogenous group of patients and SCD is a relatively rare event. Because of this there have been no prospective studies on SCD in ACHD. However, multiple retrospective studies on ICD implantation in ACHD have shown that this treatment does appear to be effective. Researchers from the Academic Medical Center have identified several risk factors for sudden cardiac death. A risk score was created using this data, which has been validated in an internal and external cohort in a retrospective setting. The design of this study, including the conception of the risk score, its calculation method and validation will be published in an international scientific peer-reviewed journal.
The hypothesis of this study is that the risk score accurately predicts the risk of sudden cardiac death.
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
- •adult (≥18 years old) patient with a diagnosis of a congenital heart defect.
排除标准
- •Patients of whom follow up is not possible, e.g. no permanent home address, living outside of or expecting to move out of the area wherein travelling to the investigating hospital outpatient clinic is possible.
- •Patients with documented sustained ventricular tachycardia or ventricular fibrillation.
- •Patients for whom the risk is not calculable because of a congenital heart disease diagnose not represented in the risk score.
- •Patients for whom the risk score is not calculable because of missing data
- •Patients with recent (<3 months ago) myocardial infarction.
- •Patients in whom the high SCD-risk status depends on an impaired ejection fraction that is expected to improve, e.g. due to tachycardiomyopathy.
- •Patients with a guideline defined contraindication for ICD implantation.
结局指标
主要结局
Sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia
时间窗: 2 years
The rate of sudden cardiac death and ventricular fibrillation or sustained ventricular tachycardia in adult congenital heart disease patients
次要结局
- Sudden cardiac death(2 years)
研究者
Joris R. de Groot
Professor of Cardiac Electrophysiology and Atrial Fibrillation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)