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An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects

Recruitingn/aAges 1 Month - anyAllFondation Hôpital Saint-Joseph
NCT06823635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
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Where

25 sites
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Magdi Yacoub Heart Foundation
Cairo, Egypt
University Hospital of Bordeaux
Bordeaux, France
Marie Lannelongue Hospital
Le Plessis-Robinson, France
Lille University Hospital
Lille, France
Toulouse University Hospital
Toulouse, France
University Children's Hospital
Tübingen, Germany
Queen Mary Hospital
Hong Kong, Hong Kong

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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