Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

NCT07715032 | Not Yet Recruiting FDA Device

• 1 other identifier: Closure of VSD
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

VSD; Pediatric Cardiology

Outcome Measures

Primary Outcomes (3)

• Procedural success rate

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

  baseline

• 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

  baseline

• Predictors of success and complications

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

  baseline

Interventions

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

VSD closure

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07