Femoral Allogenic Vein Valved Conduit for Palliative Repair of Pulmonary Atresia With Ventricular Septal Defect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Growth of pulmonary arteries
研究概览
简要总结
The aim is to compare effective growth true hypoplastic pulmonary arteries using Right Ventricle Outflow Tract Reconstruction by femoral allogenic vein valve conduit and systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)
详细描述
The use of femoral allogenic vein valve conduit for Right Ventricle Outflow Tract Reconstruction is good alternative systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt). Main advantages is straight, symmetrical, pulsating, systolic blood flow in hypoplastic pulmonary artery, which stimulate growth and prepares for a radical repair. Taking into account the absence randomized studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.
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
- 1 Day 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who met the following criteria were included:
- •Patients with PA-VSD type A and B (by Tchervenkov) scheduled for palliative surgery
- •Age less than one year
- •Confluent pulmonary artery
- •Nakata Index ≤ 120 mm2/m2.
排除标准
- •Patients who met any of the following criteria were excluded:
- •Discordant atrioventricular and/or discordant ventriculo-arterial connections
- •Concomitant pathology (pneumonia, brain damage, or enterocolitis)
- •Genetic syndromes (DiGeorge, Alagille, VACTER, CHARGE)
- •Scheduled MAPCA unifocalisation
- •Anomalous coronary arteries
- •Other surgical approaches (complete primary repair, primary unification of pulmonary blood flow, stenting RVOT, or patent ductus arteriosus, radiofrequency pulmonary valve perforation).
研究组 & 干预措施
Right ventricle outflow tract reconstruction
RVOT reconstruction used femoral allogenic vein valve conduit through ventricular fibrillation and without VSD closure
干预措施: Experimental: RVOT reconstruction by femoral allogenic vein valve conduit (Procedure)
Systemic-to-pulmonary artery shunts
systemic-to-pulmonary artery shunts (modified Blalock-Taussig shunt)
干预措施: Systemic-to-pulmonary artery shunts (Procedure)
结局指标
主要结局
Growth of pulmonary arteries
时间窗: From 6 to 12 months
-Index Nakata ≥ 150 mm/m2
次要结局
- Number of further re interventions(1 year)
- Complications(1 year)
研究者
Alexey Voitov
MD
Meshalkin Research Institute of Pathology of Circulation