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S-ICD French Cohort Study (HO...

S-ICD French Cohort Study (HONEST)

Last Updated: 2022-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-13

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sudden Cardiac Death Implantable Defibrillator User

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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S-ICD

Intervention Type DEVICE

Implantation of an S-ICD

Interventions

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S-ICD

Implantation of an S-ICD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Refusal of consent

Minimum Eligible Age

0 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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Paris Cardiovascular Research Center (HONEST Investigators)

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eloi Marijon, MD, PhD

Role: CONTACT

[email protected]

+33662833848

David Perrot, MD, MSc

Role: CONTACT

[email protected]

+33635297563‬

Facility Contacts

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Eloi Marijon, MD, PhD

Role: primary

[email protected]

+33662833848

References

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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.

Reference Type DERIVED

PMID: 40602942 (View on PubMed)

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.

Reference Type DERIVED

PMID: 40358574 (View on PubMed)

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.

Reference Type DERIVED

PMID: 37558371 (View on PubMed)

Other Identifiers

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CNIL2217196

Identifier Type: -

Identifier Source: org_study_id

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S-ICD French Cohort Study (HONEST)

Study Results

Basic Information

Brief Summary

Related Clinical Trials

French COhoRte Extra-Vascular Implantable CardiovErter DefibrillatoR

Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement

Primary Prevention ICD French Registry

MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Primary Prevention of Sudden Cardiac Death (PREV-DEATH)

Detailed Description

Conditions

Study Design

Study Groups

S-ICD

S-ICD

Interventions

S-ICD

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Centre Cardio-Thoracique de Monaco

Centre Cardiologique du Nord

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Centre Hospitalier Annecy Genevois

Centre Hospitalier Bretagne Atlantique

Centre Hospitalier William Morey - Chalon sur Saône

Centre Hospitalier du Pays d'Aix

Centre Hospitalier Albi

Centre Hospitalier Antibes - Juan Les Pins

Centre Hospitalier Argenteuil

Centre Hospitalier Henri Duffaut - Avignon

Centre Hospitalier Auxerre

Centre Hospitalier de Bastia

Centre Hospitalier de Bigorre - Tarbes

Boulogne sur Mer Hospital Center

Centre Hospitalier de Carcassonne

Centre hospitalier de Chambéry

Centre Hospitalier of Chartres

Centre Hospitalier de Compiègne

Centre Hospitalier de Haguenau (Est France)

Centre hospitalier de la Polynésie française - Papeete

Centre Hospitalier de La Rochelle

Centre Hospitalier de Lens

Ch Mont de Marsan

Centre Hospitalier de Montauban

Centre Hospitalier de Moulins Yzeure

Centre Hospitalier de PAU

Centre Hospitalier de Perigueux

Centre hospitalier de Perpignan

Centre Hospitalier de Roubaix

Centre Hospitalier de Saint-Brieuc

Centre Hospitalier de Troyes

Centre Hospitalier de Valence

Centre Hospitalier de Valenciennes

Centre Hospitalier Departemental Vendee

Centre Hospitalier le Mans

Centre Hospitalier Eure-Seine

Centre Hospitalier Henri Mondor - Aurillac

Centre Hospitalier Intercommunal Castres-Mazamet

Centre Hospitalier Jacques Cœur - Bourges

Centre Hospitalier Libourne

Centre Hospitalier Princesse Grace

Centre Hospitalier Régional d'Orléans

Hôpital NOVO

Centre Hospitalier Rodez

Centre Hospitalier Saint Joseph Saint Luc de Lyon

Central Hospital Saint Quentin

Centre Hospitalier Saintonge - Saintes

Centre Hospitalier Sud Francilien

Centre Hospitalier Territorial- Nouméa

Centre Hospitalier Toulon

Centre Hospitalier Universitaire de Saint Etienne

Poissy-Saint Germain Hospital

CHR Mercy - Metz

Amiens University Hospital

University Hospital, Angers

Centre Hospitalier Universitaire de Besancon

University Hospital, Clermont-Ferrand