S-ICD French Cohort Study (HONEST)

Sudden Cardiac Death Clinical Trial

— HONEST  

Official title:

coHOrte fraNcaise Des dEfibrillateurs Sous cuTanés

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302115
• Other study ID #: CNIL2217196
• Status: Recruiting
• Start date: October 13, 2012
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: Paris Sudden Death Expertise Center
• Contact: Eloi Marijon, MD, PhD
• Phone: +33662833848
• Email: eloi.marijon[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal of consent

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Implantable Defibrillator User
• Sudden Cardiac Death

Intervention

Device:
• S-ICD
Implantation of an S-ICD

Locations

Country	Name	City	State
France	Paris Cardiovascular Research Center (HONEST Investigators)	Paris

Sponsors (137)

Lead Sponsor

Collaborator

Paris Sudden Death Expertise Center

Amiens SAS, Amiens University Hospital, Bichat Hospital, Central Hospital Saint Quentin, Centre Cardio-Thoracique de Monaco, Centre Cardiologique du Nord, Centre Hospitalier Albi, Centre Hospitalier Annecy Genevois, Centre Hospitalier Antibes - Juan Les Pins, Centre Hospitalier Argenteuil, Centre Hospitalier Auxerre, Centre Hospitalier Bretagne Atlantique, 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 de Compiègne, Centre Hospitalier de Haguenau (Est France), Centre hospitalier de la Polynésie française - Papeete, Centre Hospitalier de La Rochelle, Centre Hospitalier de Lens, 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 du Pays d'Aix, Centre Hospitalier Eure-Seine, Centre Hospitalier Felix Guyon, Centre Hospitalier Henri Duffaut - Avignon, Centre Hospitalier Henri Mondor - Aurillac, Centre Hospitalier Intercommunal Castres-Mazamet, Centre Hospitalier Jacques Cœur - Bourges, Centre Hospitalier le Mans, Centre Hospitalier Libourne, Centre Hospitalier of Chartres, Centre Hospitalier Princesse Grace, Centre Hospitalier Régional d'Orléans, Centre Hospitalier Régional et Universitaire de Brest, Centre Hospitalier René Dubos, Centre Hospitalier Rodez, Centre Hospitalier Saint Joseph Saint Luc de Lyon, Centre Hospitalier Saintonge - Saintes, Centre Hospitalier Sud Francilien, Centre Hospitalier Territorial- Nouméa, Centre Hospitalier Toulon, Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire de la Réunion, Centre Hospitalier Universitaire de Nice, Centre Hospitalier Universitaire de Nimes, Centre Hospitalier Universitaire de Saint Etienne, Centre Hospitalier Universitaire Dijon, Centre Hospitalier William Morey - Chalon sur Saône, Ch Mont de Marsan, CHR Mercy - Metz, CHU de Lille, CHU de Nancy, CHU de Nantes, CHU de Reims, CHU de Rouen - Accueil, CHU de Tours, CHU Rennes - Hopital Pontchaillou, Clinique Alleray Labrouste, Clinique Belledonne - Grenoble, Clinique Claude Bernard - Metz, Clinique du Millenaire, Clinique du Parc - Castelnau le Lez - Montpellier, Clinique du Tonkin - Lyon - Villeurbane, 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 Joseph, Liège, Clinique Saint Pierre - Perpignan, Clinique Saint Vincent - Besancon, Clinique Saint-Gatien - Tours, Clinique Saint-Hilaire, CMC Ambroise Paré, European Georges Pompidou Hospital, GCS Cardiologie - Bayonne, Groupe Hospitalier de Bretagne Sud, Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Groupe Hospitalier du Havre, Henri Mondor University Hospital, Hopital Antoine Beclere, Hôpital de la Croix-Rousse, Hôpital de la Timone, Hôpital Marie Lannelongue - Le Plessis Robinson, Hôpital Necker-Enfants Malades, 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, Hôpital Saint Philibert - Lille - GHICL, Hospices Civils de Lyon, Hospital St. Joseph, Marseille, France, Institut Jacques Cartier - Massy, Institut Mutualiste Montsouris, Pitié-Salpêtrière Hospital, Poissy-Saint Germain Hospital, Poitiers University 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, Raincy Montfermeil Hospital Group, University Hospital, Angers, University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Clermont-Ferrand, University Hospital, Grenoble, University Hospital, Limoges, University Hospital, Marseille, University Hospital, Montpellier, University Hospital, Strasbourg, France, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular Arrhythmias	Rate of appropriate ICD therapies for ventricular tachycardia / fibrillation	Through study completion, an average of 5 years
Primary	Device-Related Complications	Rate of complications related to ICD including inappropriate therapies, infection, lead or generator dysfunction	Through study completion, an average of 5 years
Primary	Overall and Specific Mortalities	Overall mortality and causes of death	Through study completion, an average of 5 years
Secondary	Early Device-Related Complications	Complications occurring within the 3 months following implantation	3 months
Secondary	Late Device-Related Complications	Complications occurring after 3 months following implantation	Through study completion, an average of 5 year
Secondary	Stratified Analyses by Sex, Underlying Heart Disease	Primary and secondary outcomes studied by sex and types of heart diseases	Through study completion, an average of 5 year