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OpenTrials
Completed

NCT Number: NCT05349162

Epicardial vs. Transvenous ICDs in Children

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.

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Key information

Conditions

Implantable Cardioverter Defibrillator Complications Implantable Defibrillator User

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICD implantation
  • Age < 18 years

Exclusion criteria

  • Absence of patient's consent

Treatment and study plan

Implantable cardioverter defibrillator use

Device

Implantation of an implantable cardioverter defibrillator (epicardial or transvenous)

Primary outcomes

  1. Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention)

    Time frame: up to 15 years

    Number 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

Sponsors and collaborators

Lead sponsor

Paris Cardiovascular Research Center (Inserm U970)

Other Gov

Collaborators

  • Hôpital Necker-Enfants Malades

Registry information

Official study title

Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children

Important dates

Study start
2003
Primary completion
2021
Study completion
2022
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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