Outcomes Of Interventional Catheterization In Infants Less Than 3 Months With Critical Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Delineation of failure of the procedure and its causes
研究概览
简要总结
Congenital heart disease is the most common birth defect affecting mostly 1 in 100 births(1), critical congenital heart disease is when there is low systemic cardiac output which requires urgent surgery or catheter intervention in the first year of life(2), in low-income countries CCHD is associated with severe high mortality rate due to low health resources, in high-income countries, CCHD is associated with life-long morbidities and a high burden on the health care systems(1-3)
详细描述
CCHD are classified into three major components:
Left heart obstructions representing 30-40%, complete transposition of the great arteries (mostly 30%), and right heart obstructions (20-30%).
CCHD may present with signs of low cardiac output and hypoperfusion in case of duct dependent systemic circulation or central cyanosis not responding to oxygen in duct dependent pulmonary circulation or two parallel circulations.
Critical congenital heart disease is classified into :
- Congenital heart disease with duct-dependent systemic blood flow (SBF) as:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Hours 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants less than 3 months of age with critical congenital heart disease requiring urgent cardiac catheter intervention including
- •Critical valvular aortic stenosis requiring aortic valvuoplasty.
- •Pulmonary valvuloplasty for critical valvular pulmonary stenosis.
- •Pulmonary valvuloplasty in pulmonary atresia with intact IVS after exclusion of RV-dependent coronary circulation.
- •PDA stenting in duct dependent congenital cyanotic heart disease.
- •Atrial septostomy to enhance atrial mixing (in transposition of great arteries with restrictive or no inter-atrial communication).
- •Balloon angioplasty of native coarctation as a palliative measure to stabilize a patient with severely depressed ventricular function.
排除标准
- •patent ductus arteriosus closure
- •percutaneous temporary pacemaker implantation for arrhythmia
- •diagnostic catheterization.
- •prematurity
- •low birth weight
- •bleeding diathesis
结局指标
主要结局
Delineation of failure of the procedure and its causes
时间窗: immediate post procedure up to 1montn
failure of cardiac catheterization with urgent referral to surgery
the effect of cardiac catheter interventions in infants < 3 months with critical congenital heart disease on morbidity and mortality
时间窗: 6 months post catheterization
the success rates of urgent cardiac cathetrization Type of procedure. Procedural outcome:
次要结局
- Complications of trans catheter intervention(6 month)
- the least and sufficient Procedure time , the radiation time and its side effects(6 months)
研究者
YHAlattar
Principal Investigator
Assiut University