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

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).

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.

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.