Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT03363932
Eligibility Criteria:
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.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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT03363932
Study Brief:
Protocol Section:
NCT03363932