Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03363932

French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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:

    • endocarditis,
    • 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,
    • stroke
    • Complete atrioventricular block (AVB)
    • Pulmonary Arterial Hypertension (PAH)
    • heart failure
    • cardiovascular deaths,
    • severe haemolysis (= requiring transfusion or interventional catheterization or surgical).

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: FRANCISCO

Important dates

Study start
2018
Primary completion
2021
Study completion
2030
First posted
Dec 6, 2017
Registry last updated
Feb 13, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.