NCT05302115

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

7.2 years

First QC Date

December 11, 2020

Last Update Submit

May 7, 2022

Conditions

Sudden Cardiac DeathImplantable Defibrillator User

Keywords

outcomesappropriate shockcomplicationssubcutaneous

Outcome Measures

Primary Outcomes (3)

  • Ventricular Arrhythmias

    Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation

    Through study completion, an average of 5 years

  • Device-Related Complications

    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

    Overall mortality and causes of death

    Through study completion, an average of 5 years

Secondary Outcomes (3)

  • 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

Study Arms (1)

S-ICD

Device: S-ICD

Interventions

S-ICDDEVICE

Implantation of an S-ICD

S-ICD

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All S-ICD patients implanted in France since October 13, 2012

You may qualify if:

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

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Cardiovascular Research Center (HONEST Investigators)

Paris, 75015, France

RECRUITING

Related Publications (3)

  • Kerkouri F, Eschalier R, Fareh S, Marquie C, Ait Said M, Amara W, Anselme F, Badoz M, Behar N, Bordachar P, El Bouazzaoui R, Champ Rigot L, Chauvin M, Chevalier P, Da Costa A, Defaye P, Deharo JC, Fauchier L, Gandjbakhch E, Gitenay E, Gourraud JB, Guenancia C, de Guillebon M, Guy-Moyat B, Hermida A, Hourdain J, Jacon P, Khattar P, Laredo M, Jesel L, Lellouche N, Leclercq C, Mansourati V, Maury P, Mondoly P, Pasquie JL, Peyrol M, Pierre B, Ploux S, Potelle C, Sadoul N, Sellal JM, Varlet E, Garcia R, Probst V, Boveda S, Marijon E; HONEST Study Investigators. Defibrillation Testing During Implantation of Subcutaneous Implantable Cardioverter Defibrillators. J Am Coll Cardiol. 2025 Jul 8;86(1):32-45. doi: 10.1016/j.jacc.2025.04.048.

    PMID: 40602942DERIVED

  • Sousonis V, Jacon P, Kerkouri F, Garcia R, Marquie C, Amara W, Anselme F, Badenco N, Behar N, Belhameche M, Bouzeman A, Fareh S, Guy-Moyat B, Hermida A, Hourdain J, Jesel L, Khattar P, Khoueiry Z, Laurent G, Manenti V, Mechulan A, Menet A, Milhem A, Mondoly P, Ollitrault P, Perrot D, Peyrol M, Pierre B, Sadoul N, Scarlatti D, Taieb J, Vanesson C, Winum P, Probst V, Marijon E, Defaye P, Boveda S; HONEST Study Investigators. S-ICD Implantation Following TV-ICD: Insights Into Patients With Infections and Abandoned Leads: The HONEST Cohort. JACC Clin Electrophysiol. 2025 Sep;11(9):2049-2060. doi: 10.1016/j.jacep.2025.04.020. Epub 2025 Apr 24.

    PMID: 40358574DERIVED

  • Waldmann V, Marquie C, Bessiere F, Perrot D, Anselme F, Badenco N, Barra S, Bertaux G, Blangy H, Bordachar P, Boveda S, Chauvin M, Clementy N, Clerici G, Combes N, Defaye P, Deharo JC, Durand P, Duthoit G, Eschalier R, Fauchier L, Garcia R, Geoffroy O, Gitenay E, Gourraud JB, Guenancia C, Iserin L, Jacon P, Jesel-Morel L, Kerkouri F, Klug D, Koutbi L, Labombarda F, Ladouceur M, Laurent G, Leclercq C, Maille B, Maltret A, Massoulie G, Mondoly P, Ninni S, Ollitrault P, Pasquie JL, Pierre B, Pujadas P, Champ-Rigot L, Sacher F, Sadoul N, Schatz A, Winum P, Milliez PU, Probst V, Marijon E. Subcutaneous Implantable Cardioverter-Defibrillators in Patients With Congenital Heart Disease. J Am Coll Cardiol. 2023 Aug 15;82(7):590-599. doi: 10.1016/j.jacc.2023.05.057.

    PMID: 37558371DERIVED

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Eloi Marijon, MD, PhD

CONTACT

+33662833848eloi.marijon@inserm.fr

David Perrot, MD, MSc

CONTACT

+33635297563‬daveperrot@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

March 31, 2022

Study Start

October 13, 2012

Primary Completion

December 31, 2019

Study Completion

December 31, 2024

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

FR(1)