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An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
RECRUITINGSponsored by Fondation Hôpital Saint-Joseph
Actively Recruiting
SponsorFondation Hôpital Saint-Joseph
Started2025-01-01
Est. completion2026-12-31
Eligibility
Age1 Month+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06823635
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).
Eligibility
Age: 1 Month+Healthy volunteers accepted
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.
Conditions2
Heart DiseasePerimembranous Ventricular Septal Defect
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Actively Recruiting
SponsorFondation Hôpital Saint-Joseph
Started2025-01-01
Est. completion2026-12-31
Eligibility
Age1 Month+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06823635