S-ICD French Cohort Study (HONEST)

Paris Sudden Death Expertise Center

Status: Enrolling

Conditions: Implantable Defibrillator User; Sudden Cardiac Death

Treatments: Device: S-ICD

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT05302115

CNIL2217196

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who require S-ICD implantation (new or battery replacement)

Exclusion criteria

• Refusal of consent

Trial design

5,000 participants in 1 patient group

S-ICD

Treatment:

Device: S-ICD