Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 131
- Primary Endpoint
- Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 0 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ICD implantation
- •Age < 18 years
Exclusion Criteria
- •Absence of patient's consent
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported