French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 218
- 试验地点
- 4
- 主要终点
- Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload
研究概览
简要总结
Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude.
The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are:
- To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events.
- To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically.
This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient at least 1 year old
- •Having a perimembranous VSD with pulmonary overload defined by "a left-right shunt and a z-score of the left ventricular end-diastolic diameter> = 2".
- •Consent for inclusion in the study was signed by the parents or legal guardian for minors, by the patient for the adults.
排除标准
- •Congenital heart disease associated with membranous VSD
- •Stenosis of the left ventricular outflow tract (average gradient ≥20 mmHg)
- •Aortic insufficiency
- •sub-pulmonary stenosis (mean gradient ≥20 mmHg)
- •Tricuspid insufficiency ≥ 2/4
- •History of cardiac surgery or cardiac interventional catheterization
- •Shunt right-left through the VSD
- •Pulmonary Arterial Hypertension defined on the data of a catheterization by PAPM> = 25 mmHg and pulmonary vascular resistance> = 3 UW.m²
- •Active infectious endocarditis
- •Cardiac insufficiency according to the "ESC 2016" criteria, other than a symptomatology of pulmonary hyper flow during the first year of life. Heart failure is defined by the presence of clinical signs of heart failure associated with a structural or cardiac functional abnormality resulting in a decrease in cardiac output and / or an increase in filling pressures.
- •History of persistent or chronic atrial arrhythmia (atrial flutter, atrial tachycardia or chronic atrial fibrillation or requiring electrical cardioversion, drug therapy or endocavitary ablation)
- •History of sustained ventricular arrhythmia (duration> = 30 seconds)
- •Complete BAV
- •Refusal of the patient or guardian to participate in the study
结局指标
主要结局
Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload
时间窗: 5 years of follow-up
The main criterion "cardiovascular event" is a composite criterion. At least 1 of the following criteria is required for the primary criterion to be met: * endocarditis, * aortic stenosis (mean gradient\> 20 mmHg) * aortic insufficiency * left ventricular outflow tract stenosis (mean gradient\> 20 mmHg) * tricuspid insufficiency ≥2 * surgery or cardiac interventional catheterization for an abnormality in relation to the VSD (other than simple closing) * persistent supraventricular arrhythmias, sustained ventricular arrhythmia, * stroke * Complete atrioventricular block (AVB) * Pulmonary Arterial Hypertension (PAH) * heart failure * cardiovascular deaths, * severe haemolysis (= requiring transfusion or interventional catheterization or surgical).
次要结局
- Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 5 years of follow-up(5 years of follow-up)
- Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure(1 year of follow-up)
- Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 10 years of follow-up.(10 years of follow-up)
- Anatomical predictive elements of events at 5 years of follow-up.(5 years of follow-up)