Clinical Evaluation of Transcatheter Closure and Surgery of Perimembranous Ventricular Septal Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Major adverse events
研究概览
简要总结
The purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.
详细描述
Perimembranous Ventricular septal defect (VSD) is the most common congenital cardiac malformation and constitutes over 20% of all congenital cardiac disease. Though conventional surgery for VSD is a widely accepted procedure with minimal operative mortality, it carries a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. The newly appeared transcatheter device closure technique provides an alternative to surgical closure. However, the mid-to-long term effects of this technique using occluders is not clear. The aim of this study was to evaluate the safety and effectiveness of transcatheter closure of perimembranous ventricular septal defects using septal occluders.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ventricular septal defects eligible for transcatheter closure.
排除标准
- •Patients less than 2 years old. Patients not suitable for transcatheter closure. Patients comorbid with other diseases.
结局指标
主要结局
Major adverse events
时间窗: till study end
Major adverse events included but were not limited to death during or after the procedure because of complications of the procedure,cAVB requiring pacemaker implantation, thromboembolism, and new-onset valvular regurgitation requiring surgical repair.
次要结局
- Minor adverse events(Till study end)
研究者
Jian Yang
Dr Jian Yang
Xijing Hospital