Clinical trial NCT05302115: S-ICD French Cohort Study (HONEST)
Official title: coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sudden Cardiac Death
Implantable Defibrillator User
Keywords: outcomes
appropriate shock
complications
subcutaneous
Lead sponsor: Paris Sudden Death Expertise Center
Sponsor class: OTHER
Collaborators: name: Centre Cardio-Thoracique de Monaco
name: Centre Cardiologique du Nord
name: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
name: Centre Hospitalier Annecy Genevois
name: Centre Hospitalier Bretagne Atlantique
name: Centre Hospitalier William Morey - Chalon sur Saône
name: Centre Hospitalier du Pays d'Aix
name: Centre Hospitalier Albi
name: Centre Hospitalier Antibes - Juan Les Pins
name: Centre Hospitalier Argenteuil
name: Centre Hospitalier Henri Duffaut - Avignon
name: Centre Hospitalier Auxerre
name: Centre Hospitalier de Bastia
name: Centre Hospitalier de Bigorre - Tarbes
name: Boulogne sur Mer Hospital Center
name: Centre Hospitalier de Carcassonne
name: Centre hospitalier de Chambéry
name: Centre Hospitalier of Chartres
name: Centre Hospitalier de Compiègne
name: Centre Hospitalier de Haguenau (Est France)
name: Centre hospitalier de la Polynésie française - Papeete
name: Centre Hospitalier de La Rochelle
name: Centre Hospitalier de Lens
name: Ch Mont de Marsan
name: Centre Hospitalier de Montauban
name: Centre Hospitalier de Moulins Yzeure
name: Centre Hospitalier de PAU
name: Centre Hospitalier de Perigueux
name: Centre hospitalier de Perpignan
name: Centre Hospitalier de Roubaix
name: Centre Hospitalier de Saint-Brieuc
name: Centre Hospitalier de Troyes
name: Centre Hospitalier de Valence
name: Centre Hospitalier de Valenciennes
name: Centre Hospitalier Departemental Vendee
name: Centre Hospitalier le Mans
name: Centre Hospitalier Eure-Seine
name: Centre Hospitalier Henri Mondor - Aurillac
name: Centre Hospitalier Intercommunal Castres-Mazamet
name: Centre Hospitalier Jacques Cœur - Bourges
name: Centre Hospitalier Libourne
name: Centre Hospitalier Princesse Grace
name: Centre Hospitalier Régional d'Orléans
name: Hôpital NOVO
name: Centre Hospitalier Rodez
name: Centre Hospitalier Saint Joseph Saint Luc de Lyon
name: Central Hospital Saint Quentin
name: Centre Hospitalier Saintonge - Saintes
name: Centre Hospitalier Sud Francilien
name: Centre Hospitalier Territorial- Nouméa
name: Centre Hospitalier Toulon
name: Centre Hospitalier Universitaire de Saint Etienne
name: Poissy-Saint Germain Hospital
name: CHR Mercy - Metz
name: Amiens University Hospital
name: University Hospital, Angers
name: Centre Hospitalier Universitaire de Besancon
name: University Hospital, Clermont-Ferrand
name: University Hospital, Bordeaux
name: University Hospital, Caen
name: Centre Hospitalier Universitaire de la Réunion
name: CHU de Lille
name: University Hospital, Limoges
name: University Hospital, Montpellier
name: Central Hospital, Nancy, France
name: Nantes University Hospital
name: Poitiers University Hospital
name: CHU de Rouen - Accueil
name: University Hospital, Strasbourg, France
name: University Hospital, Toulouse
name: CHU de Tours
name: Centre Hospitalier Universitaire Dijon
name: Centre Hospitalier Felix Guyon
name: University Hospital, Grenoble
name: Centre Hospitalier Régional et Universitaire de Brest
name: Centre Hospitalier Universitaire de Nice
name: CHU de Reims
name: CHU Rennes - Hopital Pontchaillou
name: Clinique Alleray Labrouste
name: CMC Ambroise Paré
name: Clinique Belledonne - Grenoble
name: Clinique Claude Bernard - Metz
name: Clinique du Millenaire
name: Clinique du Parc - Castelnau le Lez - Montpellier
name: Clinique du Tonkin - Lyon - Villeurbane
name: Clinique Saint-Hilaire
name: Clinique Les Fontaines - Melun
name: Clinique Louis Pasteur Essey-lès-Nancy
name: Clinique Oreliance - Orléans
name: Clinique Pasteur Toulouse
name: Clinique Rhône Durance - Avignon
name: Clinique Saint Augustin - Bordeaux
name: Clinique Saint Georges - Nice
name: Clinique Saint Pierre - Perpignan
name: Clinique Saint Vincent - Besancon
name: Clinique Saint-Gatien - Tours
name: Clinique Saint Joseph, Liège
name: GCS Cardiologie - Bayonne
name: Groupe Hospitalier de Bretagne Sud
name: Groupe Hospitalier du Havre
name: Raincy Montfermeil Hospital Group
name: European Georges Pompidou Hospital
name: Hopital Antoine Beclere
name: Bichat Hospital
name: Centre Hospitalier Universitaire de Nīmes
name: Hôpital de la Croix-Rousse
name: Hôpital de la Timone
name: Henri Mondor University Hospital
name: Hôpital Marie Lannelongue - Le Plessis Robinson
name: Hôpital Necker-Enfants Malades
name: University Hospital, Marseille
name: Hopital Nord Franche-Comte
name: Hôpital Privé Arnault Tzanck - Mougins - Sophia Antipolis
name: Hôpital privé Bois Bernard - Lens
name: Hôpital privé Clairval - Marseille
name: Hôpital privé Claude Galien - Quincy-sous-Sénart
name: Hôpital Privé de la Loire- Saint Etienne
name: Hôpital Privé de Parly II - Le Chesnay
name: Hôpital privé du Confluent - Nantes
name: Hôpital privé Le Bois - Lille MetropoleHôpital Privé Les Franciscaines - Nîmes
name: Hôpital Privé Marseille - Beauregard
name: Hôpital privé Saint-Martin - Caen
name: Hospital St. Joseph, Marseille, France
name: Hôpital Saint Philibert - Lille - GHICL
name: Hospices Civils de Lyon
name: Institut Jacques Cartier - Massy
name: Institut Mutualiste Montsouris
name: Pitié-Salpêtrière Hospital
name: Pôle Santé République
name: Pôle Santé Sud - Le Mans
name: Polyclinique Les Fleurs - Toulon
name: Polyclinique Lyon-Nord - Rillieux
name: Polyclinique Reims-Bezannes-Courlancy
name: Polyclinique Saint Laurent - Rennes
name: Polyclinique Vauban - Valencienne
name: Amiens SAS
First posted: 2022-03-31
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All S-ICD patients implanted in France since October 13, 2012

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Refusal of consent

Primary outcomes:
measure: Ventricular Arrhythmias
timeFrame: Through study completion, an average of 5 years
measure: Device-Related Complications
timeFrame: Through study completion, an average of 5 years
measure: Overall and Specific Mortalities
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Early Device-Related Complications
timeFrame: 3 months
measure: Late Device-Related Complications
timeFrame: Through study completion, an average of 5 year
measure: Stratified Analyses by Sex, Underlying Heart Disease
timeFrame: Through study completion, an average of 5 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Paris Cardiovascular Research Center (HONEST Investigators)
Study officials:
References: