French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

NCT03363932 | Active Not Recruiting

• 1 other identifier: 17.10.55
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 4

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.

Conditions

Congenital Heart Disease

Keywords

Ventricular septal defect; Congenital heart disease; Outcome

Outcome Measures

Primary Outcomes (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).

  5 years of follow-up

Secondary Outcomes (4)

• Anatomical predictive elements of events at 5 years of follow-up.

  5 years 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

  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.

  10 years of follow-up

Study Arms (1)

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.

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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".

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead

Study Sites (4)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, France

Location

Hopital Europeen Georges Pompidou

Paris, France

Location

Gh Sud Hopital Haut Leveque

Pessac, France

Location

Chu Toulouse - Hopital Des Enfants

Toulouse, France

Location

Related Publications (6)

• 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.

  PMID: 21349577 BACKGROUND

• 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.

  PMID: 26844920 BACKGROUND

• 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.

  PMID: 26683488 BACKGROUND

• 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.

  PMID: 24413836 BACKGROUND

• 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.

  PMID: 21648053 BACKGROUND

• 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.

  PMID: 34551835 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 6, 2017
• Study Start: June 1, 2018
• Primary Completion: December 1, 2021
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)