[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647929":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":13,"collaborators":7,"id":17,"slug":18,"hasResults":19,"nctId":20,"briefTitle":21,"officialTitle":22,"acronym":7,"eligibilityCriteria":23,"healthyVolunteers":19,"sex":24,"minAge":25,"maxAge":26,"enrollmentInfo":27,"targetDuration":25,"studyType":30,"phases":7,"briefSummary":31,"conditions":32,"keywords":7,"overallStatus":35,"whyStopped":7,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":7},{"fullName":5,"class":6},"Assiut University","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","• Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder","VSD closure",{"type":14,"investigatorFullName":15,"investigatorTitle":16,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Noran Hasan Megally","Assistant lecturer","100647929","follow-up-after-percutaneous-device-closure-of-ventricular-septal-defects-100647929",false,"NCT07715032","Follow-up After Percutaneous Device Closure of Ventricular Septal Defects","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","Inclusion Criteria:\n\n1. Age: 6 months to 18 years\n2. Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE)\n3. Hemodynamically significant VSD with: (Imtiaz et al., 2023)\n\n   * Pulmonary blood flow (Qp) to Systemic blood flow (Qs) ≥1.5:1, OR\n   * Evidence of left ventricular volume overload, OR\n   * Pulmonary arterial hypertension (PAH) with reversible pulmonary vascular resistance\n4. Suitable anatomy for device closure as assessed by TTE and\u002For transesophageal echocardiography (TEE)\n5. Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs)\n6. Written informed consent from parents\u002Flegal guardians\n7. Assent from children ≥ 12 years (as appropriate\n\nExclusion Criteria:\n\n1. Active endocarditis or systemic infection\n2. Fixed, irreversible pulmonary arterial hypertension (pulmonary vascular resistance \\>8 Wood units\u002Fm² or ratio of pulmonary vascular resistance (Rp) to systemic vascular resistance (Rs) \\>0.5)\n3. Multiple VSDs not amenable to device closure\n4. VSD associated with complex congenital heart disease requiring surgical intervention\n5. Contraindication to antiplatelet therapy\n6. Known allergy to device materials (nickel-titanium alloy)\n7. Patient or family unwilling to comply with follow-up protocol\n8. Life expectancy \\\u003C1 year due to non-cardiac conditions\n9. Body weight \\\u003C5 kg (relative contraindication, case-by-case assessment)","ALL","6 Months","18 Years",{"count":28,"type":29},85,"ESTIMATED","OBSERVATIONAL","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.\n\nAlthough 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.\n\nThis 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.",[33,34],"VSD","Pediatric Cardiology","NOT_YET_RECRUITING","2026-07-15",{"date":38,"type":39},"2026-07-20","ACTUAL",{"date":41,"type":29},"2026-08-01",{"date":43,"type":29},"2028-08-01",{"name":5,"class":6}]