Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorAssiut University

About this trial

Ventricular septal defects (VSDs) are the most common congenital heart defects, accounting for 30-40% of congenital cardiac anomalies. They result from an abnormal opening in the interventricular septum, leading to left-to-right shunting. Clinical presentation depends on defect size and pulmonary vascular resistance, ranging from asymptomatic small defects to heart failure symptoms in infancy, with older children developing exercise intolerance or pulmonary hypertension.

Although surgical closure has long been the standard treatment, percutaneous transcatheter device closure has emerged as a less invasive alternative for selected VSD types, particularly muscular and suitable perimembranous defects. This approach offers comparable efficacy with reduced morbidity and shorter hospital stays.

This bicentric study aims to evaluate procedural success, complications, and short-term outcomes of percutaneous VSD closure in paediatric patients from Upper Egypt, providing essential data to guide clinical practice and quality improvement in tertiary cardiac centres.

Eligibility criteria

Qualifiers

Age: 6 months to 18 years

Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE)

Hemodynamically significant VSD with: (Imtiaz et al., 2023)

Pulmonary blood flow (Qp) to Systemic blood flow (Qs) ≥1.5:1, OR

Disqualifiers

Active endocarditis or systemic infection

Fixed, irreversible pulmonary arterial hypertension (pulmonary vascular resistance >8 Wood units/m² or ratio of pulmonary vascular resistance (Rp) to systemic vascular resistance (Rs) >0.5)

Multiple VSDs not amenable to device closure

VSD associated with complex congenital heart disease requiring surgical intervention

Trial design

Treatments tested in this trial

  • • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators