NCT05302115

S-ICD French Cohort Study (HONEST)

coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Paris Sudden Death Expertise Center · Academic / Other
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sudden Cardiac Death
• Implantable Defibrillator User

Interventions

Type	Name	Description
DEVICE	S-ICD	Implantation of an S-ICD

Timeline

• Start date: 2012-10-13
• Primary completion: 2019-12-31
• Completion: 2024-12-31
• First posted: 2022-03-31
• Last updated: 2022-05-12

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study