- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Procedural success rate
Lasso di tempo: baseline
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To evaluate the procedural success rate and immediate safety of percutaneous device closure of VSDs in paediatric patients.
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baseline
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Assess short-term complications
Lasso di tempo: baseline
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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
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baseline
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Predictors of success and complications
Lasso di tempo: baseline
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To evaluate clinical, echocardiographic outcomes and compare predictors of success and complications between the two tertiary centres
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baseline
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Collaboratori e investigatori
Sponsor
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Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- Closure of VSD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su • Amplatzer™ Ductal Occluder (ADO) • Amplatzer™ Muscular VSD Occluder • Amplatzer™ Membranous VSD Occluder
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Abbott Medical DevicesCompletatoDifetti del setto ventricolareStati Uniti, Canada
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Abbott Medical DevicesCompletatoPFO - Forame ovale pervio | VSD - Difetto del setto ventricolare muscolare | PIVSD - Difetto del setto ventricolare muscolare post-infartuale | ASD - Difetto del setto atrialeFrancia, Germania, Spagna, Italia, Polonia, Svizzera, Olanda
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Abbott Medical DevicesCompletatoDifetti settali cardiaci, ventricolariStati Uniti
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Abbott Medical DevicesCompletatoDifetto del setto ventricolare post-infartoStati Uniti
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Abbott Medical DevicesReclutamentoMalattie cardiache | Cardiopatia valvolare | PFO - Forame ovale pervio | VSD - Difetto del setto ventricolare muscolare | PIVSD - Difetto del setto ventricolare muscolare post-infartuale | ASD - Difetto del setto atrialeStati Uniti, Francia, Germania, Spagna, Regno Unito, Danimarca, Italia, Estonia, Polonia, Irlanda