Epicardial vs. Transvenous ICDs in Children

April 21, 2022 updated by: Paris Cardiovascular Research Center (Inserm U970)

Epicardial Versus Transvenous Implantable Cardioverter Defibrillators 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • ICD implantation
  • Age < 18 years

Exclusion Criteria:

- Absence of patient's consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paris Cardiovascular Research Center (Inserm U970)

Collaborators

Hôpital Necker-Enfants Malades

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2003

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 134526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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