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Congenital Heart DiseaseFRANCISCONCT03363932

French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

An observational study of Congenital Heart Disease, run by French Cardiology Society at 4 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 localization and the occurrence of complications. Read more about this study

Who is it for?
Ages 1 year and older
Conditions the study is for
Congenital Heart Disease
How many people
218 participants
Where
4 sitesFrance
Study dates
1 Jun 2018to Jun 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Centre Chirurgical Marie Lannelongue

    Le Plessis-Robinson

  • Hopital Europeen Georges Pompidou

    Paris

  • Gh Sud Hopital Haut Leveque

    Pessac

  • Chu Toulouse - Hopital Des Enfants

    Toulouse

Other trials in France

About this study

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:

Read more
  • 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.

Keywords
Ventricular septal defect, Congenital heart disease, Outcome
Medical subject headings
Heart Defects, Congenital, Heart Septal Defects, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03363932
Study groupRoleWhat they receive
Perimembranous VSD with high pulmonary flow rateIt 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload

    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).

    Measured: 5 years of follow-up

Secondary outcomes (4)

  1. Anatomical predictive elements of events at 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.

    Measured: 5 years of follow-up

  2. Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure

    Evolution of the left ventricular end diastolic diameter z-score one year after VSD closure

    Measured: 1 year of follow-up

  3. Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 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.

    Measured: 5 years of follow-up

  4. Incidence of cardiovascular events of "high-flow" VSDs according to the different therapeutic options at 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.

    Measured: 10 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2017
  2. Study start1 Jun 2018
  3. Primary completion1 Dec 2021
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03363932
Sponsor's protocol ID
17.10.55
Acronym
FRANCISCO
Status last verified
Feb 2025
First submitted
21 Nov 2017
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Penny DJ, Vick GW 3rd. Ventricular septal defect. Lancet. 2011 Mar 26;377(9771):1103-12. doi: 10.1016/S0140-6736(10)61339-6. Epub 2011 Feb 23.

    PubMed 21349577

  • Karonis T, Scognamiglio G, Babu-Narayan SV, Montanaro C, Uebing A, Diller GP, Alonso-Gonzalez R, Swan L, Dimopoulos K, Gatzoulis MA, Li W. Clinical course and potential complications of small ventricular septal defects in adulthood: Late development of left ventricular dysfunction justifies lifelong care. Int J Cardiol. 2016 Apr 1;208:102-6. doi: 10.1016/j.ijcard.2016.01.208. Epub 2016 Jan 23.

    PubMed 26844920

  • Videbaek J, Laursen HB, Olsen M, Hofsten DE, Johnsen SP. Long-Term Nationwide Follow-Up Study of Simple Congenital Heart Disease Diagnosed in Otherwise Healthy Children. Circulation. 2016 Feb 2;133(5):474-83. doi: 10.1161/CIRCULATIONAHA.115.017226. Epub 2015 Dec 18.

    PubMed 26683488

  • Odemis E, Saygi M, Guzeltas A, Tanidir IC, Ergul Y, Ozyilmaz I, Bakir I. Transcatheter closure of perimembranous ventricular septal defects using Nit-Occlud((R)) Le VSD coil: early and mid-term results. Pediatr Cardiol. 2014 Jun;35(5):817-23. doi: 10.1007/s00246-013-0860-8. Epub 2014 Jan 12.

    PubMed 24413836

  • Chungsomprasong P, Durongpisitkul K, Vijarnsorn C, Soongswang J, Le TP. The results of transcatheter closure of VSD using Amplatzer(R) device and Nit Occlud(R) Le coil. Catheter Cardiovasc Interv. 2011 Dec 1;78(7):1032-40. doi: 10.1002/ccd.23084. Epub 2011 Jun 6.

    PubMed 21648053

  • Guirgis L, Valdeolmillos E, Vaksmann G, Karsenty C, Houeijeh A, Hery E, Amedro P, Pangaud N, Benbrik N, Vastel C, Legendre A, Jalal Z, Hadeed K, Ladouceur M, Iserin L, Laux D, Iriart X, Warin Fresse K, Leobon B, Harchaoui S, Lambert V, Bonefoy R, Basquin A, Chalard A, Douchin S, Bouzguenda I, Denis C, Lucron H, Bosser G, Barre E, Urbina-Hiel B, Helms P, Ansquer H, Hauet Q, Leborgne AS, Cohen L, Lupoglazoff JM, Guirgis M, Gronier C, Maragnes P, Moceri P, Mauran P, Bertail C, Lefort B, Godart F, Baruteau AE, Ovaert C, Bonnet D, Combes N, Khraiche D, Houyel L, Thambo JB, Mostefa-Kara M, Hascoet S; FRANCISCO investigators. Cardiovascular events in perimembranous ventricular septal defect with left ventricular volume overload: a French prospective cohort study (FRANCISCO). Cardiol Young. 2021 Oct;31(10):1557-1562. doi: 10.1017/S1047951121002717. Epub 2021 Sep 23.

    PubMed 34551835

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Heart Disease, run by French Cardiology Society at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Cardiovascular Events at 5 Years of Perimembranous VSD with pulmonary overload (time frame: 5 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03363932, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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