NCT05302115: HONEST

S-ICD French Cohort Study (HONEST)

Status unknown Last updated 12 May 2022

What this trial tests

trial testing S-ICD in Sudden Cardiac Death in 5,000 participants. Status unknown.

Timeline

13 October 2012

Primary endpoint
31 December 2019

31 December 2024

Quick facts

Lead sponsor	Paris Sudden Death Expertise Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	13 October 2012
Primary completion	31 December 2019
Estimated completion	31 December 2024
Sites	1 location across France

Drugs / interventions tested

• S-ICD

Conditions studied

• Sudden Cardiac Death — all drugs for Sudden Cardiac Death →
• Implantable Defibrillator User — all drugs for Implantable Defibrillator User →

Sponsor

Paris Sudden Death Expertise Center

Who can join

Adults 0 to 100, any sex, with Sudden Cardiac Death or Implantable Defibrillator User. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Subcutaneous Implantable Cardioverter-Defibrillators in Patients With Congenital Heart Disease.
   Waldmann V, Marquié C, Bessière F, Perrot D, et al · · 2023 · cited 11× · PMID 37558371 · DOI 10.1016/j.jacc.2023.05.057
2. Defibrillation Testing During Implantation of Subcutaneous Implantable Cardioverter Defibrillators.
   Kerkouri F, Eschalier R, Fareh S, Marquié C, et al · · 2025 · cited 4× · PMID 40602942 · DOI 10.1016/j.jacc.2025.04.048
3. S-ICD Implantation Following TV-ICD: Insights Into Patients With Infections and Abandoned Leads: The HONEST Cohort.
   Sousonis V, Jacon P, Kerkouri F, Garcia R, et al · · 2025 · cited 1× · PMID 40358574 · DOI 10.1016/j.jacep.2025.04.020
4. The HONEST Cohort Study: Rationale and Design of a Nationwide Subcutaneous Implantable Cardioverter-Defibrillator Cohort.
   Garcia R, Kerkouri F, Marquié C, Aoudjeghout W, et al · · 2026 · PMID 41906608 · DOI 10.1016/j.jacadv.2026.102604