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Clinical Trials in Germany / NCT06823635
Recruiting Observational

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

NCT06823635 · tracked via the Priya Life Science Germany tracker
Sponsor
Fondation Hôpital Saint-Joseph
Phase
Observational
Started
2025-01-01
Last updated
2026-09-08

Condition(s) studied

Perimembranous Ventricular Septal Defect

Investigational drug(s) / intervention(s)

Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)

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.

Study 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

Sex
ALL
Min age
1 Month
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Twelve-month composite non-hierarchical net clinical success — From implant attempt to 12 months following index procedure
    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.

Trial sites (25)

FacilityCityRegionStatus
Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark Recruiting
Magdi Yacoub Heart Foundation Cairo Egypt Recruiting
University Hospital of Bordeaux Bordeaux France Enrolling By Invitation
Marie Lannelongue Hospital Le Plessis-Robinson France Recruiting
Lille University Hospital Lille France Recruiting
Toulouse University Hospital Toulouse France Recruiting
University Children's Hospital Tübingen Germany Recruiting
Queen Mary Hospital Hong Kong Hong Kong Recruiting
Hong Kong Children's Hospital Kowloon Bay Hong Kong Recruiting
National Cardiovascular Center of Harapan Kita Jakarta Indonesia Recruiting
Rajaie Cardiovascular, Medical and Research Center Tehran Iran Recruiting
Hôtel-Dieu de France University Medical Center Beirut Lebanon Recruiting
Hospital de Especialidades Pediátricas Chiapas Mexico Recruiting
The Children's Hospital Lahore Pakistan Enrolling By Invitation
Silesian Center for Heart Diseases Zabrze Poland Recruiting
Madinah Cardiac Center MC Madinah Saudi Arabia Recruiting
Skane University Hospital Skåne Sweden Recruiting
University Children's Hospital of Zurich Zurich Switzerland Recruiting
Queen Sirikit National Institute of Child Health Nonthaburi Thailand Recruiting
Prince of Songkla University Songkhla Thailand Recruiting
Ankara City Hospital Ankara Turkey (Türkiye) Recruiting
Koç University Istanbul Turkey (Türkiye) Recruiting
Umraniye Training and Education Hospital Istanbul Turkey (Türkiye) Recruiting
SBU Tepecik Training and Research Hospital Izmir Turkey (Türkiye) Recruiting
Al Jalila Children's Speciality Hospital Dubai United Arab Emirates Recruiting

More Fondation Hôpital Saint-Joseph trials in Germany

International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06823635 on ClinicalTrials.gov ↗ ← All trials in Germany