NCT05349162

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
18 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

18 years

First QC Date

April 11, 2022

Last Update Submit

April 21, 2022

Conditions

Implantable Cardioverter Defibrillator ComplicationsImplantable Defibrillator User

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Implantable cardioverter defibrillator useDEVICE

Implantation of an implantable cardioverter defibrillator (epicardial or transvenous)

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All children implanted with an ICD at necker hospital, Paris, France

You may qualify if:

  • ICD implantation
  • Age \< 18 years

You may not qualify if:

  • \- Absence of patient's consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Le Bos PA, Pontailler M, Maltret A, Kraiche D, Gaudin R, Barbanti C, Marijon E, Raisky O, Bonnet D, Waldmann V. Epicardial vs. transvenous implantable cardioverter defibrillators in children. Europace. 2023 Mar 30;25(3):961-968. doi: 10.1093/europace/euad015.

    PMID: 36735263DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 27, 2022

Study Start

January 1, 2003

Primary Completion

January 1, 2021

Study Completion

April 1, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share