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NCT05349162 Clinical Trial

Epicardial vs. Transvenous ICDs in Children

Implantable Defibrillator User Clinical Trial

Official title:
Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05349162
Other study ID # 134526
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2003
Est. completion date April 1, 2022

Study information
Verified date April 2022
Source Paris Cardiovascular Research Center (Inserm U970)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date April 1, 2022
Est. primary completion date January 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - ICD implantation - Age < 18 years Exclusion Criteria: - Absence of patient's consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Implantable cardioverter defibrillator use
Implantation of an implantable cardioverter defibrillator (epicardial or transvenous)

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Paris Cardiovascular Research Center (Inserm U970) Hôpital Necker-Enfants Malades

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention) 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 up to 15 years
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