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Epicardial vs. Transvenous ICDs in Children

Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05349162
Enrollment
131
Registered
2022-04-27
Start date
2003-01-01
Completion date
2022-04-01
Last updated
2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantable Cardioverter Defibrillator Complications, Implantable Defibrillator User

Brief summary

This observational study included all patients \<18-year-old implanted with an Implantable cardioverter defibrillator (ICD) at Necker Hospital, Paris, France, from January 2003 to January 2021. Outcomes (ICD-related complications and reinterventions) were compared between epicardial and transvenous ICDs using Cox proportional hazard models.

Interventions

DEVICEImplantable cardioverter defibrillator use

Implantation of an implantable cardioverter defibrillator (epicardial or transvenous)

Sponsors

Hôpital Necker-Enfants Malades
CollaboratorOTHER
Paris Cardiovascular Research Center (Inserm U970)
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years

Inclusion criteria

* ICD implantation * Age \< 18 years

Exclusion criteria

\- Absence of patient's consent

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention)up to 15 yearsNumber of patients in each group (epicardial and transvenous implantable cardioverter defibrillator) with an implantable cardioverter defibrillator dysfunction (dysfunction of at least one lead requiring reintervention) at the end of the follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026