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临床试验/NCT02534792
NCT02534792已完成不适用

Early Revalvulation After Fallot Repair Improves Clinical Outcome

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
1
主要终点
death

研究概览

简要总结

Aim With this retrospective study, the investigators would like to evaluate and, if possible confirm, whether earlier revalvulation of the right ventricular outflow tract is better than late revalvulation. Up to now, no analysis is done to validate this policy change.

Patient selection All patients registered in the database of paediatric and congenital cardiology of the University Hospitals in Leuven, with sufficient follow-up data, and who underwent transannular patching at repair will be included in the study.

Methodology and statistical analysis All files will be reviewed for demographic, electrocardiographic, echocardiographic, and outcome data. Besides descriptive statistics, Cox regression will be performed to detect whether the time period between repair and revalvulation influences clinical outcome (defined as death, heart failure hospitalization, redo-revalvulation, implantation of automatic defibrillator, endocarditis).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Tetralogy of Fallot patients repaired with transannulaire patch.

排除标准

  • 未提供

结局指标

主要结局

death

时间窗: 10 years

次要结局

  • re-intervention(10 years)
  • endocarditis(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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