An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorFondation Hôpital Saint-Joseph
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
Age ≥1 month and body weight ≥5 kg.
Left-to-right ventricular shunt.
Disqualifiers
Patients or legal guardians refusing the use of personal data for research purposes.
Failure to attend any follow-up visit post-discharge.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
DeviceTranscatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Patients with PmVSDs who provided informed consent and underwent transcatheter closure1 intervention
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
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 conclusion2
Closure success
Complete shunt occlusion or trivial shunt on post-procedure TTE
Time frame
From implant attempt to 12 months following index procedure3
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 procedure4
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 procedureSponsors and contacts
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Source ClinicalTrials.gov