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

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.

Recruiting

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Key information

Conditions

Tachyarrhythmia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Graz, Graz, Styria, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CorSky ICD or CRT-D

Device

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 outcomes

CorSky-related SADE-d free rate at 6 months

Time frame: 6 months

CorSky-related SADE-d free rate at 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Viehrig, Dr. rer. nat.

CONTACT

[email protected]

+49(0)1516890-1304

Konstantinia Skreka, Dr. rer. nat.

CONTACT

[email protected]

030-68905 2949

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Post-market Study for the CorSky Family of ICDs

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Jan 22, 2026
Registry last updated: Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed