Implantable Cardioverter Defibrillator ComplicationsNCT05349162
Epicardial vs. Transvenous ICDs in Children
An observational study of Implantable Cardioverter Defibrillator Complications and Implantable Defibrillator User, run by Paris Cardiovascular Research Center (Inserm U970).
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. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Implantable Cardioverter Defibrillator Complications, Implantable Defibrillator User
- What is being tested?
- Implantable cardioverter defibrillator use
- Type of treatment
- Medical device
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2003to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- Child, Adult
Study population: All children implanted with an ICD at necker hospital, Paris, France
Who may be able to join
- ICD implantation
- Age < 18 years
Who cannot join
- Absence of patient's consent
About this study
Official title: 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.
- Being tested
- Implantable cardioverter defibrillator use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable cardioverter defibrillator useDevice
Implantation of an implantable cardioverter defibrillator (epicardial or transvenous)
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Jan 2003
- Primary completion1 Jan 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implantable Cardioverter Defibrillator ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris Cardiovascular Research Center (Inserm U970)
- Sponsor type
- Other government
- Collaborators
- Hôpital Necker-Enfants Malades
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349162
- Sponsor's protocol ID
- 134526
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36735263
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Versus Transvenous Implantable Cardioverter Defibrillators in Children
- ClinicalTrials.gov ID
- NCT05349162
- Acronym / sponsor ID
- 134526
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Paris Cardiovascular Research Center (Inserm U970)Other government
- Collaborators
- Hôpital Necker-Enfants Malades
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All children implanted with an ICD at necker hospital, Paris, France
Key inclusion criteria (2 listed)
- ICD implantation
- Age < 18 years
Key exclusion criteria (1 listed)
- Absence of patient's consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable cardioverter defibrillator useImplantation of an implantable cardioverter defibrillator (epicardial or transvenous) | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Derived from this study: PubMed 36735263Le 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Cardioverter Defibrillator Complications and Implantable Defibrillator User, run by Paris Cardiovascular Research Center (Inserm U970).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with implantable cardioverter defibrillator system dysfunction (lead dysfunction requiring reintervention) (time frame: up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.