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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
Sponsor:
Information provided by (Responsible Party):
French Cardiology Society

Brief 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. 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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sébastien HASCOET +33 (0)1 40 94 24 29 hascoets@gmail.com

Locations
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France
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis Robinson, France
Contact: Sébastien HASCOET         
Hopital Europeen Georges Pompidou Recruiting
Paris, France
Contact: Magalie LADOUCEUR         
Gh Sud Hopital Haut Leveque Recruiting
Pessac, France
Contact: Jean-Benoît THAMBO         
Chu Toulouse - Hopital Des Enfants Recruiting
Toulouse, France
Contact: Khaled HADEED         
Sponsors and Collaborators
French Cardiology Society
Publications:
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Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT03363932    
Other Study ID Numbers: 17.10.55
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by French Cardiology Society:
Ventricular septal defect
Congenital heart disease
Outcome
Additional relevant MeSH terms:
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Heart Diseases
Heart Septal Defects
Heart Septal Defects, Ventricular
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities