Congenital Heart Malformations Clinical Trial
Official title:
Evolution of Two Cohorts of Children (Univentricular and Bi-ventricular Heart) After Strapping of the Pulmonary Artery
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05101746 -
Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass
|
Phase 2/Phase 3 |