Epicardial vs. Transvenous ICDs in Children
Sponsor
Paris Cardiovascular Research Center (Inserm U970) (Other)
Overall Status
Completed
CT.gov ID
NCT05349162
Collaborator
Hôpital Necker-Enfants Malades (Other)
131
231
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
131 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children
Actual Study Start Date
:
Jan 1, 2003
Actual Primary Completion Date
:
Jan 1, 2021
Actual Study Completion Date
:
Apr 1, 2022
Outcome Measures
Primary Outcome Measures
- Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention) [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
0 Years
to 18 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
-
ICD implantation
-
Age < 18 years
Exclusion Criteria:
- Absence of patient's consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Paris Cardiovascular Research Center (Inserm U970)
- Hôpital Necker-Enfants Malades
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Paris Cardiovascular Research Center (Inserm U970)
ClinicalTrials.gov Identifier:
NCT05349162
Other Study ID Numbers:
- 134526
First Posted:
Apr 27, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No