Safety and Performance Evaluation of CorSky Family of ICDs and CRT-Ds
Colección de datos
Recopilados desde hoy en adelante - ProspectivoEnfermedad del sistema de conducción cardíaco+5
+ Arritmias Cardíacas
+ Enfermedades Cardiovasculares
Otro
Uso de métodos específicos que no están cubiertos por los modelos estándar para abordar preguntas de investigación únicas.Resumen
Fecha de inicio: 1 de junio de 2026
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 151 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 99 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.