A Randomized Controlled Trial of Minimally Invasive Transthoracic Device Closure in the Treatment of Patients With Perimembranous Ventricular Septal Defect
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- the success rate of the operation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of minimally invasive transthoracic device closure of ventricular septal defect. This is a multi-center randomized controlled trial. Because of the characteristics of this surgical clinical trials, surgeons, ultrasonic department doctors, anesthesiologists, operating room nurses and intensive care unit nurses are all need to be informed. Therefore the results of this trial need to be system evaluated through objective methods to reduce bias.
详细描述
Several examinations need to be done in all the patients, including X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function, electrolytes, coagulation function and infectious index checks. And they will be divided into two groups after they have obtained informed consent: surgical group (50 cases); closure group (50 cases). If the closure failed, the patients in closure group will be converted to surgical repair with cardiopulmonary bypass .
Recheck X-ray, electrocardiogram, echocardiogram, blood routine examination, liver and kidney function and electrolytes need to be done in all the patients two days after operation. The patients were followed up by X-ray, electrocardiogram, echocardiogram at the first month, third month, sixth month and the first year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥3 months
- •Patients with isolated perimembranous ventricular septal defect with hemodynamic abnormalities. Diameter of the defect is greater than 3mm, and less than 10mm
排除标准
- •Para adverse ventricular septal defect
- •Muscular ventricular septal defect, subpulmonic ventricular septal defect and septal leaflet posterior atrioventricular canal ventricular septal defect
- •Patients with severe pulmonary hypertension in right-to-left shunt
- •Patients with obvious aortic valve prolapse, with moderate or severe aortic regurgitation
- •Infective endocarditis, and heart cavity neoplasm
- •Patients with other cardiovascular malformations, which require surgery with cardiopulmonary bypass to correct at the same period
结局指标
主要结局
the success rate of the operation
时间窗: index procedure (day 0)
The definition of a successful operation: shunt disappeared
次要结局
- thoracic fluid volume(index procedure (day 0))
- postoperative hospital stay(7 days after operation or before discharge)
- operating time(index procedure (day 0))
- postoperative ventilator support time(index procedure (day 0))
- adverse events(12 months)
- blood transfusion(index procedure (day 0))
- costs(7 days after operation or before discharge)
研究者
Pan Xiangbin
Associate chief physician in pediatric cardiac surgery
Chinese Academy of Medical Sciences, Fuwai Hospital