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临床试验/NCT03047343
NCT03047343已完成不适用

Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 79 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
发起方
入组人数
79
试验地点
1
主要终点
Sex

研究概览

简要总结

Pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment to newborns suffering from congenital heart defects, characterized by an increase in blood flow and pulmonary blood pressure.

The intervention consists of placing a band around the pulmonary artery. This band causes an artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. It acts as a first step, preparing the ground for a future definitive repair intervention.

It is mainly used in the context of septal defects, atrio-ventricular canal defects or uni-ventricular hearts.

The complications linked to strapping include, among others, the erosion of the band in the artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular insufficiency, the obstruction of the coronary artery and an ineffective strapping.

The early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and 13.6%, while strapping readjustment rates oscillate around 20%. It is assumed that the mortality is linked to the nature of the cardial malformation (uni-ventricular or bi-ventricular) rather than the procedure itself.

This retrospective study aims to evaluate the intra-hospital and extra-hospital mortality rate of pulmonary artery strapping, as well as the readjustment rate within two groups of patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting from a bi-ventricular cardiac reparation. The aim is to determine the short term mortality rate of the intervention and the incidence of complications within the hospital, within the two groups.

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

  • All patients treated with pulmonary artery strapping between 2005 and 2016 at the Queen Fabiola Children Hospital

排除标准

  • Outdated indications

结局指标

主要结局

Sex

时间窗: 12 years

Sex of the patient

SpO2

时间窗: 12 years

pre-surgery oxygen saturation

Weight

时间窗: 12 years

Weight of the patient at the time of the intervention

Exact diagnosis

时间窗: 12 years

Exact diagnosis at the time of the intervention

Total number of interventions

时间窗: 12 years

Total number of interventions

Date of death

时间窗: 12 years

If applicable, date of death of the patient

Exact date of intervention

时间窗: 12 years

Exact calender date of intervention

Date of birth

时间窗: 12 years

Date of birth of the patient

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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