NCT06823635

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Perimembranous Ventricular Septal Defect

Interventions

Type	Name	Description
DEVICE	Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)	Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

18 sites across 12 countries: Denmark, France, Germany, Indonesia, Iran, Lebanon, Mexico, Pakistan, Poland, Saudi Arabia, Turkey (Türkiye), United Arab Emirates