S-ICD French Cohort Study (HONEST) (HONEST)
May 7, 2022 updated by: Paris Sudden Death Expertise Center
coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés
Implantable cardioverter-defibrillators have been proven to be effective in the prevention of sudden cardiac death in high-risk patients.
However, it is well acknowledged that such a strategy could be optimised, especially through new technologies/devices.
Data on the entirely sub-cutaneous implantable cardioverter defibrillator (S-ICD) published so far come from high-volume centers and/or selected populations.
The HONEST Cohort -taking the opportunity of a unique scenario with a single manufacturer and remote monitoring system available- aims to collect retrospectively baseline information as well as follow-up of all patients implanted with an S-ICD in France since the first implant in October 13, 2012 until December 31, 2019.
An extended prospective yearly follow-up will be carried out since January 1, 2020 until December 31, 2024.
Study Overview
Status
Status
Recruiting
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Observational
Enrollment (Anticipated)
Enrollment
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
Study Contact
- Name: Eloi Marijon, MD, PHD
- Phone Number: +33662833848
- Email: eloi.marijon@inserm.fr
Study Contact Backup
- Name: David Perrot, MD, MSc
- Phone Number: +33635297563
- Email: daveperrot@gmail.com
Study Locations
-
-
-
Paris, France, 75015
- Recruiting
- Paris Cardiovascular Research Center (HONEST Investigators)
-
Contact:
- Eloi Marijon, MD, PHD
- Phone Number: +33662833848
- Email: eloi.marijon@inserm.fr
-
-
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
Eligibility Criteria
Ages Eligible for Study
1 second to 100 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All S-ICD patients implanted in France since October 13, 2012
Description
Inclusion Criteria:
- All patients who require S-ICD implantation (new or battery replacement)
Exclusion Criteria:
- Refusal of 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
Number of groups / cohorts
1
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
S-ICD
|
Implantation of an S-ICD
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventricular Arrhythmias
Time Frame: Through study completion, an average of 5 years
|
Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation
|
Through study completion, an average of 5 years
|
|
Device-Related Complications
Time Frame: Through study completion, an average of 5 years
|
Rate of complications related to ICD including inappropriate therapies, infection, lead or generator dysfunction
|
Through study completion, an average of 5 years
|
|
Overall and Specific Mortalities
Time Frame: Through study completion, an average of 5 years
|
Overall mortality and causes of death
|
Through study completion, an average of 5 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early Device-Related Complications
Time Frame: 3 months
|
Complications occurring within the 3 months following implantation
|
3 months
|
|
Late Device-Related Complications
Time Frame: Through study completion, an average of 5 year
|
Complications occurring after 3 months following implantation
|
Through study completion, an average of 5 year
|
|
Stratified Analyses by Sex, Underlying Heart Disease
Time Frame: Through study completion, an average of 5 year
|
Primary and secondary outcomes studied by sex and types of heart diseases
|
Through study completion, an average of 5 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Sponsor
Collaborators
Collaborators
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)
Study Start
October 13, 2012
Primary Completion (ACTUAL)
Primary Completion
December 31, 2019
Study Completion (ANTICIPATED)
Study Completion
December 31, 2024
Study Registration Dates
First Submitted
First Submitted
December 11, 2020
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
March 20, 2022
First Posted (ACTUAL)
First Posted
March 31, 2022
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
May 12, 2022
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
May 7, 2022
Last Verified
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CNIL2217196
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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.