Safety and Performance Evaluation of CorSky Family of ICDs and CRT-Ds
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladie du système de conduction cardiaque+5
+ Arythmies cardiaques
+ Maladies Cardiovasculaires
Autre
Méthodes concernant des questions de recherche très spécifiques.Résumé
Date de début de l'étude : 1 juin 2026
Date à laquelle le premier participant a commencé l'étude.BIOTRONIK introduces the CorSky family, a new generation of Implantable Cardioverter Defibrillators (ICDs). These devices are an upgrade to the current Acticor/Rivacor family, carrying over all the features of the iShock/iShock_BC implant and programmer software. The CorSky family also includes new features, some of which are unique to BIOTRONIK ICDs, while others are a result of unification with the Amvia pacemaker family. This study aims to verify the safety and effectiveness of the CorSky Family of ICDs and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The study focuses on patients who require these devices, with the goal of ensuring that these new devices meet the needs of the patients and improve their care.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.151 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 99 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * Standard indication for ICD or CRT-D therapy according to clinical guidelines * Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker * Ability to understand the nature of the study. * Ability and willingness to perform all on-site follow-up visits at the study site. * Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept. Exclusion Criteria: * For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia * For VR-T DX and CRT-DX: Patients requiring atrial pacing * Planned for His-Bundle-Pacing * Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months * Pregnant or breast feeding. * Age less than 18 years. * Participation in an interventional clinical investigation in parallel to this study. , * Life-expectancy less than 12 months.