BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CorSky ICD or CRT-D.
- Who it may be relevant to
- Registry conditions: Tachyarrhythmia, Heart Failure. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Czechia, Germany, Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post-market Study for the CorSky Family of ICDs
Overview
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
- Device CorSky 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.
Primary outcome measures
- CorSky-related SADE-d free rate at 6 months [Time frame: 6 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Czechia · 2 centers
- Fakultní nemocnice u sv. Anny v Brně — Brno
- Nemocnice Ceske Budejovice, a.s. — České Budějovice
Germany · 2 centers
- Universitätsklinikum Würzburg — Würzburg
- SRH Wald-Klinikum Gera GmbH — Gera
Hungary · 2 centers
- Semmelweis University — Budapest
- University of Pécs — Pécs
Austria · 1 center
- Medizinische Universität Graz — Graz
Identifiers
NCT: NCT07360158 · TA121