An observational study in Perimembranous Ventricular Septal Defect, sponsored by Fondation Hôpital Saint-Joseph. Recruiting at 25 sites in 17 countries. Open to participants aged 1 Month and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).
This is a non-randomized, multicenter, international, non-interventional, observational, retrospective post-marketing clinical follow-up study designed to evaluate the feasibility, safety, and efficacy of transcatheter closure of perimembranous ventricular septal defects (PmVSD) using commercially available device occluders, whether specifically designed for this purpose or used off-label.
59 studies on the registry are indexed under Heart Septal Defects, Ventricular; 9 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 100 across 25 observational studies indexed under Heart Septal Defects, Ventricular.
Browse Heart Septal Defects, Ventricular studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 346 studies on the registry; 51 are open to participants now.
Compared within Heart Septal Defects, Ventricular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients, regardless of gender or geographical location, with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and underwent transcatheter closure using commercially available occluder devices, whether specifically designed for this purpose or used off-label, were followed according to local hospital protocols.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
Also known as: Percutaneous closure of perimembranous ventricular septal defects, Endovascular closure of perimembranous ventricular septal defects
Twelve-month composite non-hierarchical net clinical success
Defined as simultaneous achievement of technical implantation success at procedure conclusion (device successfully deployed and released in the intended position), closure success (complete occlusion or trivial residual shunt), and absence of major adverse device-related events (MADREs), through 12 months.
Time frame: From implant attempt to 12 months following index procedure
Technical success
Successful device deployment and release into the intented position with stable device position confirmed via post-procedure transthoracic echocardiography (TTE).
Time frame: From implant attempt to procedure conclusion
Closure success
Complete shunt occlusion or trivial shunt on post-procedure TTE
Time frame: From implant attempt to 12 months following index procedure
Freedom from major device-related major adverse events
Absence of procedure or device-related major adverse events, including: * Device erosion * Device migration or embolization requiring catheter or surgical intervention. * Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment. * New or worsened aortic regurgitation (of mild grade or greater) requiring device removal, close monitoring, or intervention. * New or worsened tricuspid regurgitation (of moderate grade or greater) requiring device removal, close monitoring, or intervention. * Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention. * Thromboembolic events requiring device removal, thrombolytic therapy, catheter, or surgical intervention. * Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention. * Device-related left or right ventricular outflow tract obstruction * Cardiac tamponade
Time frame: From implant attempt to 12 months following index procedure
Minor complications
Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).
Time frame: From implant attempt to 60 months following index procedure
Late-onset device-related major adverse events (MADREs)
Absence of procedure or device-related major adverse events, including: * Device erosion * Device migration or embolization requiring catheter or surgical intervention. * Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment. * New or worsened aortic regurgitation (of mild grade or greater) requiring device removal, close monitoring, or intervention. * New or worsened tricuspid regurgitation (of moderate grade or greater) requiring device removal, close monitoring, or intervention. * Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention. * Thromboembolic events requiring device removal, thrombolytic therapy, catheter, or surgical intervention. * Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention. * Device-related left or right ventricular outflow tract obstruction * Cardiac tamponade * Death
Time frame: From 12 months to 60 months following index procedure
Functional and quality-of-life measures
Change in NYHA/ROSS functional class, and in pediatric patients, catch-up growth.
Time frame: From implant attempt to 48-month post-procedure
Plan to share: No
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Heart Septal Defects, Ventricular →
Fondation Hôpital Saint-Joseph →