Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 22
- 主要终点
- Closure of Muscular Ventricular Septal Defects
研究概览
简要总结
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
详细描述
The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
- •Age < 18 years old
排除标准
- •Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
- •Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease
- •Patients with perimembranous (close to the aortic valve) VSD
- •Patients < 3 kg
- •Patients with sepsis (local/generalized)
- •Patients with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
- •Inability to obtain informed consent
研究组 & 干预措施
Main Cohort
Device closure with the AMPLATZER Muscular VSD Occluder for patients with muscular ventricular septal defects which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
干预措施: Device closure with the AMPLATZER Muscular VSD Occluder (Device)
结局指标
主要结局
Closure of Muscular Ventricular Septal Defects
时间窗: 5 years
Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder
次要结局
未报告次要终点