French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload (FRANCISCO)
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|ClinicalTrials.gov Identifier: NCT03363932|
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : August 7, 2019
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.
|Condition or disease|
|Congenital Heart Disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||June 2030|
Perimembranous VSD with high pulmonary flow rate
It is an observational study, no intervention or examination will be realized for the sole purpose of the study. Patient management will be at the discretion of referral cardiologists according to the practices of the centers.
As part of the usual follow-up of these patients, the participating centers collect the clinical and echocardiography data from inclusion and the following year, as well as data from a functional assessment at baseline and at one year. and the collection of cardiovascular events at 5 years and 10 years of follow-up.
Data from a possible percutaneous or surgical closure procedure will be collected. The indication of VSD closure will be left to the discretion of participating centers. There will be no recommendation for percutaneous or surgical closure of VSD for the sole purpose of this observatory.
- Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload [ Time Frame: 5 years of follow-up ]
The main criterion "cardiovascular event" is a composite criterion. At least 1 of the following criteria is required for the primary criterion to be met:
- aortic stenosis (mean gradient> 20 mmHg)
- aortic insufficiency
- left ventricular outflow tract stenosis (mean gradient> 20 mmHg)
- tricuspid insufficiency ≥2
- surgery or cardiac interventional catheterization for an abnormality in relation to the VSD (other than simple closing)
- persistent supraventricular arrhythmias, sustained ventricular arrhythmia,
- Complete atrioventricular block (AVB)
- Pulmonary Arterial Hypertension (PAH)
- heart failure
- cardiovascular deaths,
- severe haemolysis (= requiring transfusion or interventional catheterization or surgical).
- Anatomical predictive elements of events at 5 years of follow-up. [ Time Frame: 5 years of follow-up ]The event criterion meets the same definition as the primary judgment criterion. The association between anatomical elements (size of the VSD, presence of aneurysm, diameter and depth of the aneurysm, septo-aortic angulation) and cardiovascular events will be studied.
- Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure [ Time Frame: 1 year of follow-up ]Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure
- Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 5 years of follow-up [ Time Frame: 5 years of follow-up ]Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options (medical - percutaneous closure - surgical closure) at 5 years of follow-up. The event criterion meets the same definition as the primary judgment criterion.
- Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 10 years of follow-up. [ Time Frame: 10 years of follow-up ]Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options (medical - percutaneous closure - surgical closure) at 10 years of follow-up. The event criterion meets the same definition as the primary judgment criterion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03363932
|Contact: Sébastien HASCOET||+33 (0)1 40 94 24 firstname.lastname@example.org|
|Centre Chirurgical Marie Lannelongue||Recruiting|
|Le Plessis Robinson, France|
|Contact: Sébastien HASCOET|
|Hopital Europeen Georges Pompidou||Recruiting|
|Contact: Magalie LADOUCEUR|
|Gh Sud Hopital Haut Leveque||Recruiting|
|Contact: Jean-Benoît THAMBO|
|Chu Toulouse - Hopital Des Enfants||Recruiting|
|Contact: Khaled HADEED|