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Completed

NCT Number: NCT03047343

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.

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Key information

Conditions

Congenital Heart Malformations

Sex eligibility

All sexes

Study type

Observational

Primary location

HUDERF

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Outdated indications

Treatment and study plan

Retrospective data extraction in medical files

Other

Retrospective data extraction in medical files

Primary outcomes

  1. Date of birth

    Time frame: 12 years

    Date of birth of the patient

  2. Sex

    Time frame: 12 years

    Sex of the patient

  3. Weight

    Time frame: 12 years

    Weight of the patient at the time of the intervention

  4. Exact diagnosis

    Time frame: 12 years

    Exact diagnosis at the time of the intervention

  5. Exact date of intervention

    Time frame: 12 years

    Exact calender date of intervention

  6. Total number of interventions

    Time frame: 12 years

    Total number of interventions

  7. SpO2

    Time frame: 12 years

    pre-surgery oxygen saturation

  8. Date of death

    Time frame: 12 years

    If applicable, date of death of the patient

Sponsors and collaborators

Lead sponsor

Pierre Wauthy

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2017
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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