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S-ICD French Cohort Study (HONEST)

Sponsor
Paris Sudden Death Expertise Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05302115
Collaborator
Centre Cardio-Thoracique de Monaco (Other), Centre Cardiologique du Nord (Other), Groupe Hospitalier de la Region de Mulhouse et Sud Alsace (Other), Centre Hospitalier Annecy Genevois (Other), Centre Hospitalier Bretagne Atlantique (Other), Centre Hospitalier William Morey - Chalon sur Saône (Other), Centre Hospitalier du Pays d'Aix (Other), Centre Hospitalier Albi (Other), Centre Hospitalier Antibes - Juan Les Pins (Other), Centre Hospitalier Argenteuil (Other), Centre Hospitalier Henri Duffaut - Avignon (Other), Centre Hospitalier Auxerre (Other), Centre Hospitalier de Bastia (Other), Centre Hospitalier de Bigorre - Tarbes (Other), Centre Hospitalier de Boulogne sur Mer (Other), Centre Hospitalier de Carcassonne (Other), Centre hospitalier de Chambéry (Other), Centre Hospitalier of Chartres (Other), Centre Hospitalier de Compiègne (Other), Centre Hospitalier de Haguenau (Est France) (Other), Centre hospitalier de la Polynésie française - Papeete (Other), Centre Hospitalier de La Rochelle (Other), Centre Hospitalier de Lens (Other), Ch Mont de Marsan (Other), Centre Hospitalier de Montauban (Other), Centre Hospitalier de Moulins Yzeure (Other), Centre Hospitalier de PAU (Other), Centre Hospitalier de Perigueux (Other), Centre hospitalier de Perpignan (Other), Centre Hospitalier de Roubaix (Other), Centre Hospitalier de Saint-Brieuc (Other), Centre Hospitalier de Troyes (Other), Centre Hospitalier de Valence (Other), Centre Hospitalier de Valenciennes (Other), Centre Hospitalier Departemental Vendee (Other), Centre Hospitalier le Mans (Other), Centre Hospitalier Eure-Seine (Other), Centre Hospitalier Henri Mondor - Aurillac (Other), Centre Hospitalier Intercommunal Castres-Mazamet (Other), Centre Hospitalier Jacques Cœur - Bourges (Other), Centre Hospitalier Libourne (Other), Centre Hospitalier Princesse Grace (Other), Centre Hospitalier Régional d'Orléans (Other), Centre Hospitalier René Dubos (Other), Centre Hospitalier Rodez (Other), Centre Hospitalier Saint Joseph Saint Luc de Lyon (Other), Central Hospital Saint Quentin (Other), Centre Hospitalier Saintonge - Saintes (Other), Centre Hospitalier Sud Francilien (Other), Centre Hospitalier Territorial- Nouméa (Other), Centre Hospitalier Toulon (Other), Centre Hospitalier Universitaire de Saint Etienne (Other), Poissy-Saint Germain Hospital (Other), CHR Mercy - Metz (Other), Amiens University Hospital (Other), University Hospital, Angers (Other), Centre Hospitalier Universitaire de Besancon (Other), University Hospital, Clermont-Ferrand (Other), University Hospital, Bordeaux (Other), University Hospital, Caen (Other), Centre Hospitalier Universitaire de la Réunion (Other), CHU de Lille (Other), University Hospital, Limoges (Other), University Hospital, Montpellier (Other), CHU de Nancy (Other), CHU de Nantes (Other), Poitiers University Hospital (Other), CHU de Rouen - Accueil (Other), University Hospital, Strasbourg, France (Other), University Hospital, Toulouse (Other), CHU de Tours (Other), Centre Hospitalier Universitaire Dijon (Other), Centre Hospitalier Felix Guyon (Other), University Hospital, Grenoble (Other), Centre Hospitalier Régional et Universitaire de Brest (Other), Centre Hospitalier Universitaire de Nice (Other), CHU de Reims (Other), CHU Rennes - Hopital Pontchaillou (Other), Clinique Alleray Labrouste (Other), CMC Ambroise Paré (Other), Clinique Belledonne - Grenoble (Other), Clinique Claude Bernard - Metz (Other), Clinique du Millenaire (Other), Clinique du Parc - Castelnau le Lez - Montpellier (Other), Clinique du Tonkin - Lyon - Villeurbane (Other), Clinique Saint-Hilaire (Other), Clinique Les Fontaines - Melun (Other), Clinique Louis Pasteur Essey-lès-Nancy (Other), Clinique Oreliance - Orléans (Other), Clinique Pasteur Toulouse (Other), Clinique Rhône Durance - Avignon (Other), Clinique Saint Augustin - Bordeaux (Other), Clinique Saint Georges - Nice (Other), Clinique Saint Pierre - Perpignan (Other), Clinique Saint Vincent - Besancon (Other), Clinique Saint-Gatien - Tours (Other), Clinique Saint Joseph, Liège (Other), GCS Cardiologie - Bayonne (Other), Groupe Hospitalier de Bretagne Sud (Other), Groupe Hospitalier du Havre (Other), Raincy Montfermeil Hospital Group (Other), European Georges Pompidou Hospital (Other), Hopital Antoine Beclere (Other), Bichat Hospital (Other), Centre Hospitalier Universitaire de Nīmes (Other), Hôpital de la Croix-Rousse (Other), Hôpital de la Timone (Other), Henri Mondor University Hospital (Other), Hôpital Marie Lannelongue - Le Plessis Robinson (Other), Hôpital Necker-Enfants Malades (Other), University Hospital, Marseille (Other), Hopital Nord Franche-Comte (Other), Hôpital Privé Arnault Tzanck - Mougins - Sophia Antipolis (Other), Hôpital privé Bois Bernard - Lens (Other), Hôpital privé Clairval - Marseille (Other), Hôpital privé Claude Galien - Quincy-sous-Sénart (Other), Hôpital Privé de la Loire- Saint Etienne (Other), Hôpital Privé de Parly II - Le Chesnay (Other), Hôpital privé du Confluent - Nantes (Other), Hôpital privé Le Bois - Lille MetropoleHôpital Privé Les Franciscaines - Nîmes (Other), Hôpital Privé Marseille - Beauregard (Other), Hôpital privé Saint-Martin - Caen (Other), Hospital St. Joseph, Marseille, France (Other), Hôpital Saint Philibert - Lille - GHICL (Other), Hospices Civils de Lyon (Other), Institut Jacques Cartier - Massy (Other), Institut Mutualiste Montsouris (Other), Pitié-Salpêtrière Hospital (Other), Pôle Santé République (Other), Pôle Santé Sud - Le Mans (Other), Polyclinique Les Fleurs - Toulon (Other), Polyclinique Lyon-Nord - Rillieux (Other), Polyclinique Reims-Bezannes-Courlancy (Other), Polyclinique Saint Laurent - Rennes (Other), Polyclinique Vauban - Valencienne (Other), Amiens SAS (Other)
5,000
Enrollment
1
Location
146.6
Anticipated Duration (Months)
34.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: S-ICD

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés
Actual Study Start Date :
Oct 13, 2012
Actual Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
S-ICD

Device: S-ICD
Implantation of an S-ICD

Outcome Measures

Primary Outcome Measures

  1. Ventricular Arrhythmias [Through study completion, an average of 5 years]

    Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation

  2. Device-Related Complications [Through study completion, an average of 5 years]

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

  3. Overall and Specific Mortalities [Through study completion, an average of 5 years]

    Overall mortality and causes of death

Secondary Outcome Measures

  1. Early Device-Related Complications [3 months]

    Complications occurring within the 3 months following implantation

  2. Late Device-Related Complications [Through study completion, an average of 5 year]

    Complications occurring after 3 months following implantation

  3. Stratified Analyses by Sex, Underlying Heart Disease [Through study completion, an average of 5 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All patients who require S-ICD implantation (new or battery replacement)
Exclusion Criteria:
  • Refusal of consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Paris Cardiovascular Research Center (HONEST Investigators) Paris France 75015

Sponsors and Collaborators

  • Paris Sudden Death Expertise Center
  • 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
  • Centre Hospitalier de Boulogne sur Mer
  • 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
  • Centre Hospitalier René Dubos
  • 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
  • University Hospital, Bordeaux
  • University Hospital, Caen
  • Centre Hospitalier Universitaire de la Réunion
  • CHU de Lille
  • University Hospital, Limoges
  • University Hospital, Montpellier
  • CHU de Nancy
  • CHU de Nantes
  • Poitiers University Hospital
  • CHU de Rouen - Accueil
  • University Hospital, Strasbourg, France
  • University Hospital, Toulouse
  • CHU de Tours
  • Centre Hospitalier Universitaire Dijon
  • Centre Hospitalier Felix Guyon
  • University Hospital, Grenoble
  • Centre Hospitalier Régional et Universitaire de Brest
  • Centre Hospitalier Universitaire de Nice
  • CHU de Reims
  • CHU Rennes - Hopital Pontchaillou
  • Clinique Alleray Labrouste
  • CMC Ambroise Paré
  • Clinique Belledonne - Grenoble
  • Clinique Claude Bernard - Metz
  • Clinique du Millenaire
  • Clinique du Parc - Castelnau le Lez - Montpellier
  • Clinique du Tonkin - Lyon - Villeurbane
  • Clinique Saint-Hilaire
  • Clinique Les Fontaines - Melun
  • Clinique Louis Pasteur Essey-lès-Nancy
  • Clinique Oreliance - Orléans
  • Clinique Pasteur Toulouse
  • Clinique Rhône Durance - Avignon
  • Clinique Saint Augustin - Bordeaux
  • Clinique Saint Georges - Nice
  • Clinique Saint Pierre - Perpignan
  • Clinique Saint Vincent - Besancon
  • Clinique Saint-Gatien - Tours
  • Clinique Saint Joseph, Liège
  • GCS Cardiologie - Bayonne
  • Groupe Hospitalier de Bretagne Sud
  • Groupe Hospitalier du Havre
  • Raincy Montfermeil Hospital Group
  • European Georges Pompidou Hospital
  • Hopital Antoine Beclere
  • Bichat Hospital
  • Centre Hospitalier Universitaire de Nīmes
  • Hôpital de la Croix-Rousse
  • Hôpital de la Timone
  • Henri Mondor University Hospital
  • Hôpital Marie Lannelongue - Le Plessis Robinson
  • Hôpital Necker-Enfants Malades
  • University Hospital, Marseille
  • Hopital Nord Franche-Comte
  • Hôpital Privé Arnault Tzanck - Mougins - Sophia Antipolis
  • Hôpital privé Bois Bernard - Lens
  • Hôpital privé Clairval - Marseille
  • Hôpital privé Claude Galien - Quincy-sous-Sénart
  • Hôpital Privé de la Loire- Saint Etienne
  • Hôpital Privé de Parly II - Le Chesnay
  • Hôpital privé du Confluent - Nantes
  • Hôpital privé Le Bois - Lille MetropoleHôpital Privé Les Franciscaines - Nîmes
  • Hôpital Privé Marseille - Beauregard
  • Hôpital privé Saint-Martin - Caen
  • Hospital St. Joseph, Marseille, France
  • Hôpital Saint Philibert - Lille - GHICL
  • Hospices Civils de Lyon
  • Institut Jacques Cartier - Massy
  • Institut Mutualiste Montsouris
  • Pitié-Salpêtrière Hospital
  • Pôle Santé République
  • Pôle Santé Sud - Le Mans
  • Polyclinique Les Fleurs - Toulon
  • Polyclinique Lyon-Nord - Rillieux
  • Polyclinique Reims-Bezannes-Courlancy
  • Polyclinique Saint Laurent - Rennes
  • Polyclinique Vauban - Valencienne
  • Amiens SAS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paris Sudden Death Expertise Center
ClinicalTrials.gov Identifier:
NCT05302115
Other Study ID Numbers:
  • CNIL2217196
First Posted:
Mar 31, 2022
Last Update Posted:
May 12, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Paris Sudden Death Expertise Center
outcomes
appropriate shock
complications
subcutaneous
Additional relevant MeSH terms:
Death, Sudden, Cardiac
Death

Study Results

No Results Posted as of May 12, 2022