French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

Congenital Heart Disease Clinical Trial

— FRANCISCO  

Official title:

French Observatory of Congenital Ventricular Septal Defect With Pulmonary Overload

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03363932
• Other study ID #: 17.10.55
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: June 2030

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: June 2030
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Septal Defects
• Heart Septal Defects, Ventricular

Locations

Country	Name	City	State
France	Centre Chirurgical Marie Lannelongue	Le Plessis Robinson
France	Hopital Europeen Georges Pompidou	Paris
France	Gh Sud Hopital Haut Leveque	Pessac
France	Chu Toulouse - Hopital Des Enfants	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (6)

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

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 — View Citation

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. — View Citation

Odemis E, Saygi M, Guzeltas A, Tanidir IC, Ergul Y, Ozyilmaz I, Bakir I. Transcatheter closure of perimembranous ventricular septal defects using Nit-Occlud(®) Lê 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. — View Citation

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. Review. — View Citation

Videbæk J, Laursen HB, Olsen M, Høfsten 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years of follow-up
Secondary	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	1 year of follow-up
Secondary	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.	5 years of follow-up
Secondary	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.	10 years of follow-up