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

NCT06823635

RecruitingN/A

Sponsor: Fondation Hôpital Saint-Joseph

Conditions: Perimembranous Ventricular Septal Defect

Interventions: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)

Countries: Denmark, Egypt, France, Germany, Hong Kong, Indonesia, Iran, Lebanon

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 overview

Sex: ALL

Age: 1 Month to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (25)
  • Copenhagen, Denmark
  • Cairo, Egypt
  • Bordeaux, France
  • Le Plessis-Robinson, France
  • Lille, France
  • Toulouse, France
  • Tübingen, Germany
  • Hong Kong, Hong Kong
  • Kowloon Bay, Hong Kong
  • Jakarta, Indonesia
  • Tehran, Iran
  • Beirut, Lebanon
  • Chiapas, Mexico
  • Lahore, Pakistan
  • Zabrze, Poland
  • Madinah, Saudi Arabia
  • Skåne, Sweden
  • Zurich, Switzerland
  • Nonthaburi, Thailand
  • Songkhla, Thailand
  • Ankara, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)
  • Dubai, United Arab Emirates