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Follow-up After Percutaneous Device Closure of Ventricular Septal Defects

15. juli 2026 opdateret af: Noran Hasan Megally, Assiut University

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

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

85

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

Inclusion Criteria:

  1. Age: 6 months to 18 years
  2. Confirmed diagnosis of VSD (perimembranous, muscular) by transthoracic echocardiography (TTE)
  3. 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
  4. Suitable anatomy for device closure as assessed by TTE and/or transesophageal echocardiography (TEE)
  5. Adequate rim (≥2mm) from VSD edges to cardiac valves and conduction system (for perimembranous VSDs)
  6. Written informed consent from parents/legal guardians
  7. Assent from children ≥ 12 years (as appropriate

Exclusion Criteria:

  1. Active endocarditis or systemic infection
  2. 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)
  3. Multiple VSDs not amenable to device closure
  4. VSD associated with complex congenital heart disease requiring surgical intervention
  5. Contraindication to antiplatelet therapy
  6. Known allergy to device materials (nickel-titanium alloy)
  7. Patient or family unwilling to comply with follow-up protocol
  8. Life expectancy <1 year due to non-cardiac conditions
  9. Body weight <5 kg (relative contraindication, case-by-case assessment)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedural success rate
Tidsramme: baseline
To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.
baseline
Assess short-term complications
Tidsramme: baseline
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
Tidsramme: baseline
To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. oktober 2027

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • Closure of VSD

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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