Transcatheter closure of perimembranous heart defects across centers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an international, multicenter, observational registry that collects real-world data on outcomes after transcatheter closure of perimembranous ventricular septal defects (PmVSD). It is non-randomized and retrospective, aiming to assess feasibility, safety, and effectiveness of commercially available occluders, including off-label devices. Data are gathered from multiple sites with follow-up per local protocols to understand procedural success and device performance in a broad patient population. The study includes patients aged 1 month and older with 3–<20 mm defects on the left ventricular side and a left-to-right shunt, who underwent transcatheter closure with any occluder device. No control group is specified, and follow-up adherence is required for eligibility.

Why it matters

Who can join: the full rules

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.

Where it's running

• Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Magdi Yacoub Heart Foundation
  Cairo, Egypt Recruiting
• 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

Study contacts

• Principal investigator: Raymond N. Haddad, MD, MHSc, PhDc — Marie Lannelongue Hospital, INSERM, UMR-S1358, UP-Saclay
• Study coordinator: Raymond N. Haddad, MD, MHSc, PhDc
• Email: raymondhaddad@live.com
• Phone: +33140942800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.