coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sudden Cardiac Death
- Sponsor
- Paris Sudden Death Expertise Center
- Enrollment
- 5000
- Locations
- 1
- Primary Endpoint
- Ventricular Arrhythmias
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients who require S-ICD implantation (new or battery replacement)
Exclusion Criteria
- •Refusal of consent
Outcomes
Primary Outcomes
Ventricular Arrhythmias
Time Frame: Through study completion, an average of 5 years
Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation
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
Overall and Specific Mortalities
Time Frame: Through study completion, an average of 5 years
Overall mortality and causes of death
Secondary Outcomes
- Early Device-Related Complications(3 months)
- Late Device-Related Complications(Through study completion, an average of 5 year)
- Stratified Analyses by Sex, Underlying Heart Disease(Through study completion, an average of 5 year)