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Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

ConditionsVSDPediatric Cardiology
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

This trial does not accept healthy volunteers

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 population

Paediatric patients (age ≤18 years) undergoing percutaneous device closure of VSDs at the participating centres

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Device

    VSD closure

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Procedural success rate

To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.

Time frame
baseline
2

Assess short-term complications

To assess short-term complications, including residual shunts, rhythm disturbances (especially AV block), and device-related adverse events during follow-up up to 6 months

Time frame
baseline
3

Predictors of success and complications

To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres

Time frame
baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: