CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 79 enrolled
Drug / intervention
Retrospective data extraction in medical filesother
Likely dose
Not stated in record
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Search/NCT03047343
NCT03047343N/ACompleted

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

Pierre Wauthy·observational·Posted Feb 8, 2017·Updated May 31, 2018

In Brief

An observational study evaluating Retrospective data extraction in medical files for Congenital Heart Malformations. Completed, enrolled 79 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 8, 2017
Enrollment StartMar 1, 2017
Primary CompletionMay 29, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.4 years ago

Interventions

Retrospective data extraction in medical filesother

Retrospective data extraction in medical files