Perimembranous Ventricular Septal Defect
Conditions
Keywords
Cardiovascular Abnormalities, Congenital Heart Disease, Device Closure, Heart Defects, Congenital, Heart Septal Defects, Heart Septal Defects, Ventricular, Transcatheter Interventions, Ventricular Septal Defects
Brief summary
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).
Detailed description
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.
Interventions
DEVICETranscatheter 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.
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols. 2. Defect size between 3 mm and \<20 mm on the left ventricular side, as measured by 2D echocardiography. 3. Age ≥1 month and body weight ≥5 kg. 4. Left-to-right ventricular shunt.
Exclusion criteria
1. Patients or legal guardians refusing the use of personal data for research purposes. 2. Failure to attend any follow-up visit post-discharge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Twelve-month composite non-hierarchical net clinical success | From implant attempt to 12 months following index procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | From implant attempt to procedure conclusion | Successful device deployment and release into the intented position with stable device position confirmed via post-procedure transthoracic echocardiography (TTE). |
| Closure success | From implant attempt to 12 months following index procedure | Complete shunt occlusion or trivial shunt on post-procedure TTE |
| Freedom from major device-related major adverse events | From implant attempt to 12 months following index procedure | 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 |
| Minor complications | From implant attempt to 60 months following index procedure | Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block). |
| Late-onset device-related major adverse events (MADREs) | From 12 months to 60 months following index procedure | 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 |
| Functional and quality-of-life measures | From implant attempt to 48-month post-procedure | Change in NYHA/ROSS functional class, and in pediatric patients, catch-up growth. |
Countries
Denmark, Egypt, France, Germany, Hong Kong, Indonesia, Iran, Lebanon, Mexico, Pakistan, Poland, Saudi Arabia, Sweden, Switzerland, Thailand, Turkey (Türkiye), United Arab Emirates
Contacts
CONTACTRaymond N. Haddad, MD, MHSc, PhDc
PRINCIPAL_INVESTIGATORRaymond N. Haddad, MD, MHSc, PhDc
Marie Lannelongue Hospital, INSERM, UMR-S1358, UP-Saclay
Outcome results
None listed