French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

  • STATUS
    Recruiting
  • End date
    Jun 23, 2030
  • participants needed
    200
  • sponsor
    French Cardiology Society
Updated on 23 January 2021
hypertension
ventricular septal defect
congenital heart defects
septal defect

Summary

Ventricular septal defects (VSD) are the most common cardiac congenital heart defect (about 1/3 of patients with congenital heart disease). VSD management is related to hemodynamics and anatomical localization and the occurrence of complications. Small perimembranous VSD without pulmonary hypertension and without significant left to right shunting are tolerated, whereas large VSD with pulmonary hypertension require early surgical management in the first months of life. The management uncertainties concern the medium-sized perimembranous VSD causing a significant left-right shunt but without pulmonary hypertension, which are of variable treatment (surgical correction, percutaneous treatment, medical or abstention). There are no recommendations or consensus on the preferred indication of a therapeutic attitude.

The Pediatric and Congenital Cardiology Subsidiary, within the French Society of Cardiology, set up an observatory of perimembranous VSD with significant shunting, without pulmonary hypertension the objectives of this study are:

  • To study the incidence of cardiovascular events in perimembranous VSD and search for predictive anatomical markers of events.
  • To study the evolution of echocardiographic and functional data of patients having percutaneous or surgical closure compared to patient managed medically.

This observatory will provide a better understanding of the therapeutic algorithm in the management of VSD with pulmonary overload without pulmonary hypertension.

Details
Condition Congenital Heart Disease
Clinical Study IdentifierNCT03363932
SponsorFrench Cardiology Society
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient at least 1 year old
Having a perimembranous VSD with pulmonary overload defined by "a left-right shunt and a z-score of the left ventricular end-diastolic diameter> = 2
Consent for inclusion in the study was signed by the parents or legal guardian for minors, by the patient for the adults

Exclusion Criteria

Congenital heart disease associated with membranous VSD
Stenosis of the left ventricular outflow tract (average gradient 20 mmHg)
Aortic insufficiency
sub-pulmonary stenosis (mean gradient 20 mmHg)
Tricuspid insufficiency 2/4
History of cardiac surgery or cardiac interventional catheterization
Shunt right-left through the VSD
Pulmonary Arterial Hypertension defined on the data of a catheterization by PAPM> = 25 mmHg and pulmonary vascular resistance> = 3 UW.m
Active infectious endocarditis
Cardiac insufficiency according to the "ESC 2016" criteria, other than a symptomatology of pulmonary hyper flow during the first year of life. Heart failure is defined by the presence of clinical signs of heart failure associated with a structural or cardiac functional abnormality resulting in a decrease in cardiac output and / or an increase in filling pressures
History of persistent or chronic atrial arrhythmia (atrial flutter, atrial tachycardia or chronic atrial fibrillation or requiring electrical cardioversion, drug therapy or endocavitary ablation)
History of sustained ventricular arrhythmia (duration> = 30 seconds)
Complete BAV
Refusal of the patient or guardian to participate in the study
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