跳至主要内容
临床试验/NCT03348397
NCT03348397已完成不适用

Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns : Fifteen Years' Experience

Queen Fabiola Children's University Hospital1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
1
主要终点
Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra

研究概览

简要总结

Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • neonatal patients who had a reconstruction of the right ventricular outflow tract with a pulmonary homograft or a Contegra between January 1992 and December 2014 at HUDERF

排除标准

  • 未提供

结局指标

主要结局

Comparison of mid term course between pediatric right ventricular outflow tract recontruction with homograft and contegra

时间窗: up to 195 months post right ventricular outflow tract recontruction

次要结局

  • Proportion of early conduit-related reintervention according to the Nakata index(up to 195 months post right ventricular outflow tract recontruction)
  • Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with contegra(up to 195 months post right ventricular outflow tract recontruction)
  • Proportion of early conduit-related reintervention in right ventricular outflow tract recontructed with pulmonary homograft(up to 195 months post right ventricular outflow tract recontruction)
  • Overal mortality in right ventricular outflow tract recontructed with pulmonary homograft(up to 195 months post right ventricular outflow tract recontruction)
  • Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with contegra(up to 195 months post right ventricular outflow tract recontruction)
  • Residual pulmonary arterial hypertension rate in right ventricular outflow tract recontructed with pulmonary homograft(up to 195 months post right ventricular outflow tract recontruction)
  • Proportion of early conduit-related reintervention according to the congenital heart defect diagnosis(up to 195 months post right ventricular outflow tract recontruction)
  • Overal mortality in right ventricular outflow tract recontructed with contegra(up to 195 months post right ventricular outflow tract recontruction)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验