Heart Failure, Tachyarrhythmia
Conditions
Brief summary
The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock\_BC (Ilivia Neo, Intica Neo) implant and programmer software features. The new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky). The goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.
Interventions
DEVICECorSky ICD or CRT-D
Subjects with an indication for an ICD or CRT-D device will be implanted with a CorSky device of the CorSky ICD family according to standard implantation procedures. Device programming will be done according to the medical needs of the subjects.
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CorSky-related SADE-d free rate at 6 months | 6 months | CorSky-related SADE-d free rate at 6 months |
Countries
Austria, Czechia, Germany, Hungary
Contacts
CONTACTAnja Viehrig, Dr. rer. nat.
CONTACTKonstantinia Skreka, Dr. rer. nat.
STUDY_CHAIRAlan Bulava, MD, PhD, Prof. Dr.
Fakultní nemocnice Olomouc, CZE
Outcome results
None listed