Implantable Defibrillator User, Sudden Cardiac Death
Conditions
Keywords
outcomes, appropriate shock, complications, subcutaneous
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.
Interventions
DEVICES-ICD
Implantation of an S-ICD
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
University Hospital, Bordeaux
University Hospital, Caen
Centre Hospitalier Universitaire de la Réunion
CHU de Lille
University Hospital, Limoges
University Hospital, Montpellier
Central Hospital, Nancy, France
Nantes University Hospital
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
Paris Sudden Death Expertise Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All patients who require S-ICD implantation (new or battery replacement)
Exclusion criteria
* Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular Arrhythmias | Through study completion, an average of 5 years | Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation |
| 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 |
| Overall and Specific Mortalities | Through study completion, an average of 5 years | Overall mortality and causes of death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Device-Related Complications | 3 months | Complications occurring within the 3 months following implantation |
| Late Device-Related Complications | Through study completion, an average of 5 year | Complications occurring after 3 months following implantation |
| 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 |
Countries
France
Contacts
Primary ContactEloi Marijon, MD, PhD
Backup ContactDavid Perrot, MD, MSc
Outcome results
None listed