S-ICD French Cohort Study (HONEST)

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.

Conditions

• Sudden Cardiac Death
• Implantable Defibrillator User

Interventions

DEVICE

S-ICD

Implantation of an S-ICD

Sponsors & Collaborators

• Centre Cardio-Thoracique de Monaco

  collaborator UNKNOWN

• Centre Cardiologique du Nord

  collaborator OTHER

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

  collaborator OTHER

• Centre Hospitalier Annecy Genevois

  collaborator OTHER

• Centre Hospitalier Bretagne Atlantique

  collaborator OTHER

• Centre Hospitalier William Morey - Chalon sur Saône

  collaborator OTHER

• Centre Hospitalier du Pays d'Aix

  collaborator OTHER

• Centre Hospitalier Albi

  collaborator UNKNOWN

• Centre Hospitalier Antibes - Juan Les Pins

  collaborator UNKNOWN

• Centre Hospitalier Argenteuil

  collaborator OTHER

• Centre Hospitalier Henri Duffaut - Avignon

  collaborator OTHER

• Centre Hospitalier Auxerre

  collaborator UNKNOWN

• Centre Hospitalier de Bastia

  collaborator OTHER

• Centre Hospitalier de Bigorre - Tarbes

  collaborator UNKNOWN

• Boulogne sur Mer Hospital Center

  collaborator OTHER

• Centre Hospitalier de Carcassonne

  collaborator UNKNOWN

• Centre hospitalier de Chambéry

  collaborator UNKNOWN

• Centre Hospitalier of Chartres

  collaborator OTHER

• Centre Hospitalier de Compiègne

  collaborator UNKNOWN

• Centre Hospitalier de Haguenau (Est France)

  collaborator UNKNOWN

• Centre hospitalier de la Polynésie française - Papeete

  collaborator UNKNOWN

• Centre Hospitalier de La Rochelle

  collaborator OTHER

• Centre Hospitalier de Lens

  collaborator OTHER

• Ch Mont de Marsan

  collaborator OTHER

• Centre Hospitalier de Montauban

  collaborator OTHER

• Centre Hospitalier de Moulins Yzeure

  collaborator OTHER

• Centre Hospitalier de PAU

  collaborator OTHER

• Centre Hospitalier de Perigueux

  collaborator OTHER

• Centre hospitalier de Perpignan

  collaborator OTHER

• Centre Hospitalier de Roubaix

  collaborator OTHER

• Centre Hospitalier de Saint-Brieuc

  collaborator OTHER

• Centre Hospitalier de Troyes

  collaborator OTHER

• Centre Hospitalier de Valence

  collaborator OTHER

• Centre Hospitalier de Valenciennes

  collaborator NETWORK

• Centre Hospitalier Departemental Vendee

  collaborator OTHER

• Centre Hospitalier le Mans

  collaborator OTHER

• Centre Hospitalier Eure-Seine

  collaborator OTHER

• Centre Hospitalier Henri Mondor - Aurillac

  collaborator UNKNOWN

• Centre Hospitalier Intercommunal Castres-Mazamet

  collaborator UNKNOWN

• Centre Hospitalier Jacques Cœur - Bourges

  collaborator UNKNOWN

• Centre Hospitalier Libourne

  collaborator UNKNOWN

• Centre Hospitalier Princesse Grace

  collaborator OTHER

• Centre Hospitalier Régional d'Orléans

  collaborator OTHER

• Hôpital NOVO

  collaborator OTHER

• Centre Hospitalier Rodez

  collaborator OTHER

• Centre Hospitalier Saint Joseph Saint Luc de Lyon

  collaborator OTHER

• Central Hospital Saint Quentin

  collaborator OTHER_GOV

• Centre Hospitalier Saintonge - Saintes

  collaborator UNKNOWN

• Centre Hospitalier Sud Francilien

  collaborator OTHER

• Centre Hospitalier Territorial- Nouméa

  collaborator UNKNOWN

• Centre Hospitalier Toulon

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Saint Etienne

  collaborator OTHER

• Poissy-Saint Germain Hospital

  collaborator OTHER

• CHR Mercy - Metz

  collaborator UNKNOWN

• Amiens University Hospital

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• Centre Hospitalier Universitaire de la Réunion

  collaborator OTHER

• CHU de Lille

  collaborator UNKNOWN

• University Hospital, Limoges

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Central Hospital, Nancy, France

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• CHU de Rouen - Accueil

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• CHU de Tours

  collaborator UNKNOWN

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• Centre Hospitalier Felix Guyon

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Centre Hospitalier Régional et Universitaire de Brest

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• CHU de Reims

  collaborator OTHER

• CHU Rennes - Hopital Pontchaillou

  collaborator OTHER

• Clinique Alleray Labrouste

  collaborator UNKNOWN

• CMC Ambroise Paré

  collaborator OTHER

• Clinique Belledonne - Grenoble

  collaborator UNKNOWN

• Clinique Claude Bernard - Metz

  collaborator UNKNOWN

• Clinique du Millenaire

  collaborator OTHER

• Clinique du Parc - Castelnau le Lez - Montpellier

  collaborator UNKNOWN

• Clinique du Tonkin - Lyon - Villeurbane

  collaborator UNKNOWN

• Clinique Saint-Hilaire

  collaborator OTHER

• Clinique Les Fontaines - Melun

  collaborator UNKNOWN

• Clinique Louis Pasteur Essey-lès-Nancy

  collaborator UNKNOWN

• Clinique Oreliance - Orléans

  collaborator UNKNOWN

• Clinique Pasteur Toulouse

  collaborator OTHER

• Clinique Rhône Durance - Avignon

  collaborator UNKNOWN

• Clinique Saint Augustin - Bordeaux

  collaborator UNKNOWN

• Clinique Saint Georges - Nice

  collaborator UNKNOWN

• Clinique Saint Pierre - Perpignan

  collaborator UNKNOWN

• Clinique Saint Vincent - Besancon

  collaborator UNKNOWN

• Clinique Saint-Gatien - Tours

  collaborator UNKNOWN

• Clinique Saint Joseph, Liège

  collaborator OTHER

• GCS Cardiologie - Bayonne

  collaborator UNKNOWN

• Groupe Hospitalier de Bretagne Sud

  collaborator OTHER

• Groupe Hospitalier du Havre

  collaborator OTHER

• Raincy Montfermeil Hospital Group

  collaborator NETWORK

• European Georges Pompidou Hospital

  collaborator OTHER

• Hopital Antoine Beclere

  collaborator OTHER

• Bichat Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Hôpital de la Croix-Rousse

  collaborator OTHER

• Hôpital de la Timone

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hôpital Marie Lannelongue - Le Plessis Robinson

  collaborator UNKNOWN

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• University Hospital, Marseille

  collaborator OTHER

• Hopital Nord Franche-Comte

  collaborator OTHER

• Hôpital Privé Arnault Tzanck - Mougins - Sophia Antipolis

  collaborator UNKNOWN

• Hôpital privé Bois Bernard - Lens

  collaborator UNKNOWN

• Hôpital privé Clairval - Marseille

  collaborator UNKNOWN

• Hôpital privé Claude Galien - Quincy-sous-Sénart

  collaborator UNKNOWN

• Hôpital Privé de la Loire- Saint Etienne

  collaborator UNKNOWN

• Hôpital Privé de Parly II - Le Chesnay

  collaborator OTHER

• Hôpital privé du Confluent - Nantes

  collaborator UNKNOWN

• Hôpital privé Le Bois - Lille MetropoleHôpital Privé Les Franciscaines - Nîmes

  collaborator UNKNOWN

• Hôpital Privé Marseille - Beauregard

  collaborator UNKNOWN

• Hôpital privé Saint-Martin - Caen

  collaborator UNKNOWN

• Hospital St. Joseph, Marseille, France

  collaborator OTHER

• Hôpital Saint Philibert - Lille - GHICL

  collaborator UNKNOWN

• Hospices Civils de Lyon

  collaborator OTHER

• Institut Jacques Cartier - Massy

  collaborator UNKNOWN

• Institut Mutualiste Montsouris

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• Pôle Santé République

  collaborator OTHER

• Pôle Santé Sud - Le Mans

  collaborator UNKNOWN

• Polyclinique Les Fleurs - Toulon

  collaborator UNKNOWN

• Polyclinique Lyon-Nord - Rillieux

  collaborator UNKNOWN

• Polyclinique Reims-Bezannes-Courlancy

  collaborator UNKNOWN

• Polyclinique Saint Laurent - Rennes

  collaborator UNKNOWN

• Polyclinique Vauban - Valencienne

  collaborator UNKNOWN

• Amiens SAS

  collaborator UNKNOWN

• Paris Sudden Death Expertise Center

  lead OTHER

Eligibility

Min Age

0 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-13

Primary Completion

2019-12-31

Completion

2024-12-31

FDA Device

Yes

Countries

• France

Study Locations