French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload (FRANCISCO)

February 12, 2025 updated by: French Cardiology Society

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Plessis Robinson, France
        • Centre chirurgical Marie Lannelongue
      • Paris, France
        • Hôpital Europeen Georges Pompidou
      • Pessac, France
        • Gh Sud Hopital Haut Leveque
      • Toulouse, France
        • CHU Toulouse - Hôpital des Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients who agreed to participate in the study, met the inclusion criteria, and treated in a French medical and surgical center with pediatric and congenital cardiology activity

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years of follow-up
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
1 year of follow-up
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.
5 years of follow-up
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.
10 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

December 1, 2021

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17.10.55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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