TachyarrhythmiaNCT07360158
BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
An observational study of Tachyarrhythmia and Heart Failure, run by Biotronik SE & Co. KG at 7 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tachyarrhythmia, Heart Failure
- What is being tested?
- CorSky ICD or CRT-D
- Type of treatment
- Medical device
- How many people
- 151 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 22 Jun 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Standard indication for ICD or CRT-D
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 4 countries
Czechia2 sites, 2 recruiting
- Recruiting
Fakultní nemocnice u sv. Anny v Brně
Brno, CZ-65691
Andrej Nagy, MUDr.
- Recruiting
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 37001
Ondřej Ošmera, MU Dr.
Germany2 sites, 2 recruiting
- Recruiting
SRH Wald-Klinikum Gera GmbH
Gera, Thuringia, 07548
Martin Winterhalter, Dr. med.
- Recruiting
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
Peter Johann Nordbeck, PD Dr. med.
Hungary2 sites, 2 recruiting
- Recruiting
Semmelweis University
Budapest, 1122
Béla Merkely, Dr.
- Recruiting
University of Pécs
Pécs, H-7624
Attila Kónyi, Ph. D
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Graz
Graz, Styria, 8010
Daniel Scherr, Univ.-Prof.
About this study
Official title: 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.
- Conditions
- Tachyarrhythmia, Heart Failure
- Being tested
- CorSky ICD or CRT-D
- Medical subject headings
- Tachycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorSky ICD or CRT-DDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
CorSky-related SADE-d free rate at 6 months
CorSky-related SADE-d free rate at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start22 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 151 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Bulava, MD, PhD, Prof. Dr., Study chair, Fakultní nemocnice Olomouc, CZE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360158
- Sponsor's protocol ID
- TA121
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study for the CorSky Family of ICDs
- ClinicalTrials.gov ID
- NCT07360158
- Acronym / sponsor ID
- TA121
- Conditions
- Tachyarrhythmia, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 151 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Standard indication for ICD or CRT-D
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorSky ICD or CRT-DSubjects 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. | Device | – |
Primary outcome
CorSky-related SADE-d free rate at 6 months
Time frame: 6 months
CorSky-related SADE-d free rate at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Bulava, MD, PhD, Prof. Dr. study chair
Fakultní nemocnice Olomouc, CZE
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachyarrhythmia and Heart Failure, run by Biotronik SE & Co. KG at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Czechia, Germany, Hungary, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anja Viehrig, Dr. rer. nat. (+49(0)1516890-1304, anja.viehrig@biotronik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CorSky-related SADE-d free rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.