Status:
ACTIVE_NOT_RECRUITING
French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload
Lead Sponsor:
French Cardiology Society
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
1+ years
Brief 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 loc...
Eligibility Criteria
Inclusion
- 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
- 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.m²
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2030
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT03363932
Start Date
June 1 2018
End Date
June 1 2030
Last Update
February 13 2025
Active Locations (4)
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1
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France
2
Hopital Europeen Georges Pompidou
Paris, France
3
Gh Sud Hopital Haut Leveque
Pessac, France
4
Chu Toulouse - Hopital Des Enfants
Toulouse, France