MedTrace Logo

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

NCT03047343 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2018-05-31

No results posted yet for this study

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.

Conditions

  • Congenital Heart Malformations

Interventions

OTHER

Retrospective data extraction in medical files

Retrospective data extraction in medical files

Sponsors & Collaborators

  • Pierre Wauthy

    lead OTHER

Principal Investigators

  • Nicolas Bellofatto Piazza · HUDERF

  • Pierre Wauthy, MD · CHU Brugmann

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-05-29
Completion
2018-05-29

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03047343 on ClinicalTrials.gov