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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
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
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Magdi Yacoub Heart Foundation
Cairo, Egypt
RECRUITINGUniversity Hospital of Bordeaux
Bordeaux, France
ENROLLING_BY_INVITATIONMarie Lannelongue Hospital
Le Plessis-Robinson, France
RECRUITINGLille University Hospital
Lille, France
RECRUITINGToulouse University Hospital
Toulouse, France
RECRUITINGUniversity Children's Hospital
Tübingen, Germany
RECRUITINGQueen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGHong Kong Children's Hospital
Kowloon Bay, Hong Kong
RECRUITINGNational Cardiovascular Center of Harapan Kita
Jakarta, Indonesia
RECRUITING...and 15 more locations
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