Follow-up After Percutaneous Device Closure of Ventricular Septal Defects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder.
- Who it may be relevant to
- Registry conditions: VSD, Pediatric Cardiology. Basic parameters: 6 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outcomes and Short-term Follow-up After Percutaneous Device Closure of Ventricular Septal Defects: A Study From Two Tertiary Pediatric Cardiac Care Centers in Upper Egypt
Overview
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.
Detailed description
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.
Diagnosis is primarily established by transthoracic echocardiography, which accurately defines defect anatomy, shunt severity, ventricular function, and pulmonary artery pressures. Management is individualized according to hemodynamic significance, with small asymptomatic defects managed conservatively and significant defects requiring intervention following initial medical therapy.
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.
Recent studies report high procedural success rates (95-98%) using evolving device technologies, including Amplatzer™ and newer asymmetric occluders. However, outcome data from developing regions remain limited, highlighting the need for population-specific evidence.
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.
Interventions
- Device • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder
VSD closure
Primary outcome measures
- Procedural success rate [Time frame: baseline]
- Assess short-term complications [Time frame: baseline]
- Predictors of success and complications [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- 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
- Evidence of left ventricular volume overload, OR
- Pulmonary arterial hypertension (PAH) with reversible pulmonary vascular resistance
- Suitable anatomy for device closure as assessed by TTE and/or transesophageal echocardiography (TEE)
- Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs)
- Written informed consent from parents/legal guardians
- Assent from children ≥ 12 years (as appropriate
Exclusion criteria
- 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
- Contraindication to antiplatelet therapy
- Known allergy to device materials (nickel-titanium alloy)
- Patient or family unwilling to comply with follow-up protocol
- Life expectancy <1 year due to non-cardiac conditions
- Body weight <5 kg (relative contraindication, case-by-case assessment)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07715032 · Closure of VSD