NCT07360158 BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
| NCT ID | NCT07360158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biotronik SE & Co. KG |
| Condition | Tachyarrhythmia |
| Study Type | OBSERVATIONAL |
| Enrollment | 151 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 151 participants in total. It began in 2026-06-22 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Alan Bulava, MD, PhD, Prof. Dr.
STUDY CHAIR
Fakultní nemocnice Olomouc, CZE
Frequently Asked Questions
Who can join the NCT07360158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Tachyarrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07360158 currently recruiting?
Yes, NCT07360158 is actively recruiting participants. Contact the research team at anja.viehrig@biotronik.com for enrollment information.
Where is the NCT07360158 trial being conducted?
This trial is being conducted at Graz, Austria, Brno, Czechia, České Budějovice, Czechia, Würzburg, Germany and 3 additional locations.
Who is sponsoring the NCT07360158 clinical trial?
NCT07360158 is sponsored by Biotronik SE & Co. KG. The principal investigator is Alan Bulava, MD, PhD, Prof. Dr. at Fakultní nemocnice Olomouc, CZE. The trial plans to enroll 151 participants.