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BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs

Recruitingn/aAges 18 Years - 99 YearsAllBiotronik SE & Co. KG
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • CorSky ICD or CRT-D
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Where

7 sites
Medizinische Universität Graz
Graz, Austria
Fakultní nemocnice u sv. Anny v Brně
Brno, Czechia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, Czechia
Universitätsklinikum Würzburg
Würzburg, Germany
SRH Wald-Klinikum Gera GmbH
Gera, Germany
Semmelweis University
Budapest, Hungary
University of Pécs
Pécs, Hungary
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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