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Sudden Cardiac DeathHONESTNCT05302115

S-ICD French Cohort Study (HONEST)

An observational study of Sudden Cardiac Death and Implantable Defibrillator User, run by Paris Sudden Death Expertise Center at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 100 years
What is being tested?
S-ICD
Type of treatment
Medical device
How many people
5,000 participants
Where
1 siteFrance
Study dates
13 Oct 2012to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Refusal of consent

Trial locations and contacts

1 site in 1 country.

Eloi Marijon, MD, PhD contact

+33662833848

eloi.marijon@inserm.fr

David Perrot, MD, MSc contact

+33635297563‬

daveperrot@gmail.com

France1 site, 1 recruiting

  • Paris Cardiovascular Research Center (HONEST Investigators)

    Paris, 75015

    Eloi Marijon, MD, PhD, +33662833848, eloi.marijon@inserm.fr

    Recruiting

Other trials in France

About this study

Official title: coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés

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.

Being tested
S-ICD
Keywords
outcomes, appropriate shock, complications, subcutaneous
Medical subject headings
Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-ICDDevice

    Implantation of an S-ICD

Study groups in NCT05302115
Study groupRoleWhat they receive
S-ICDNot described
Receives: Device: S-ICD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventricular Arrhythmias

    Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation

    Measured: Through study completion, an average of 5 years

  2. Device-Related Complications

    Rate of complications related to ICD including inappropriate therapies, infection, lead or generator dysfunction

    Measured: Through study completion, an average of 5 years

  3. Overall and Specific Mortalities

    Overall mortality and causes of death

    Measured: Through study completion, an average of 5 years

Secondary outcomes (3)

  1. Early Device-Related Complications

    Complications occurring within the 3 months following implantation

    Measured: 3 months

  2. Late Device-Related Complications

    Complications occurring after 3 months following implantation

    Measured: Through study completion, an average of 5 year

  3. Stratified Analyses by Sex, Underlying Heart Disease

    Primary and secondary outcomes studied by sex and types of heart diseases

    Measured: Through study completion, an average of 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start13 Oct 2012
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302115
Sponsor's protocol ID
CNIL2217196
Acronym
HONEST
Status last verified
May 2022
First submitted
11 Dec 2020
Last updated
12 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Garcia R, Kerkouri F, Marquie C, Ait Said M, Anselme F, Aoudjeghout W, Badenco N, Badoz M, Barra S, Barthez O, Blangy H, Bordachar P, Champ-Rigot L, Combes S, Defaye P, Deharo JC, Gandjbakhch E, Gitenay E, Gorka H, Heurtebise I, Hourdain J, Jesel L, Khris L, Lebon A, Leclercq C, Le Page S, Mechulan A, Mondoly P, Pasquie JL, Perrot D, Pierre B, Piot O, Quentin A, Rendu E, Villejoubert O, Waldmann V, Weizman O, Probst V, Boveda S, Marijon E; HONEST Investigators. Subcutaneous Implantable Cardioverter-Defibrillator Therapy in Women. JACC Clin Electrophysiol. 2026 Aug 3:S2405-500X(26)00565-7. doi: 10.1016/j.jacep.2026.06.013. Online ahead of print.

    PubMed 42554569

  • Donisi L, Kerkouri F, Marquie C, Probst V, Algalarrondo V, Al Amoura A, Badoz M, Bastard E, Behar N, Bertaux G, Bessiere F, Bordachar P, Bouzeman A, Cellarier G, Chabert JP, Champ-Rigot L, Clerici G, Da Costa A, Defaye P, Deharo JC, Delahaye C, Demasles C, Eschalier R, Fauchier L, Gaty D, Gorka H, Goujeau C, Guenancia C, Guiot A, Hermida A, Heurtebise I, Hourdain J, Jacon P, Jesel L, Jourda F, Laredo M, Lebon A, Leclercq C, Lesaffre F, Litalien J, Loose C, Mansourati V, Maury P, Mechulan A, Milhem A, Miralles A, Mizon-Gerard F, Mondoly P, Moubarak G, Pasquie JL, Perrot D, Peyrol M, Quentin A, Sadoul N, Strik M, Vannesson C, Victor F, Zanutto A, Boveda S, Marijon E, Garcia R. Early complications and long-term outcomes of patients treated with a subcutaneous cardioverter-defibrillator: temporal trends and clinical implications of the anaesthetic strategies adopted at implant. Europace. 2026 Jul 3;28(7):euag148. doi: 10.1093/europace/euag148.

    PubMed 42283457

  • Garcia R, Kerkouri F, Marquie C, Aoudjeghout W, Anselme F, Defaye P, Hourdain J, Leclercq C, Mondoly P, Perrot D, Sadoul N, Probst V, Boveda S, Marijon E; HONEST Investigators. The HONEST Cohort Study: Rationale and Design of a Nationwide Subcutaneous Implantable Cardioverter-Defibrillator Cohort. JACC Adv. 2026 Mar;5(3):102604. doi: 10.1016/j.jacadv.2026.102604.

    PubMed 41906608

  • 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.

    PubMed 40602942

  • 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.

    PubMed 40358574

  • 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.

    PubMed 37558371

Questions about this trial

What is this clinical trial studying?

An observational study of Sudden Cardiac Death and Implantable Defibrillator User, run by Paris Sudden Death Expertise Center at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eloi Marijon, MD, PhD (+33662833848, eloi.marijon@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventricular Arrhythmias (time frame: Through study completion, an average of 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05302115, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

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