Safety and Performance Evaluation of CorSky Family of ICDs and CRT-Ds
Data Collection
Collected from today forward - ProspectiveCardiac Conduction System Disease+5
+ Arrhythmias, Cardiac
+ Cardiovascular Diseases
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
Study start date: June 1, 2026
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.151 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.