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NCT07360158Recruiting

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

Post-market Study for the CorSky Family of ICDs

Source: ClinicalTrials.gov · Last updated 10 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
151 (estimated)
First submitted
14 Jan 2026
Start date
22 Jun 2026
Primary completion date
May 2027
Lead sponsor
Biotronik SE & Co. KG
NCT number
NCT07360158

What you commit to

  • Study type: Observational
  • Planned participants: 151
  • From 22 Jun 2026 to the primary completion date, May 2027
  • 7 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months

Age

  • Age less than 18 years.

Other

  • 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
  • Pregnant or breast feeding.
  • Participation in an interventional clinical investigation in parallel to this study. ,
  • Life-expectancy less than 12 months.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universität Graz
Coordinator of this site? Confirm its status
GrazAustriaRecruiting
Fakultni nemocnice u sv. Anny v Brne
Coordinator of this site? Confirm its status
BrnoCzechiaRecruiting
Nemocnice České Budějovice, a.s.
Coordinator of this site? Confirm its status
České BudějoviceCzechiaRecruiting
SRH Wald-Klinikum Gera GmbH
Coordinator of this site? Confirm its status
GeraGermanyRecruiting
Universitätsklinikum Würzburg
Coordinator of this site? Confirm its status
WürzburgGermanyRecruiting
Semmelweis University
Coordinator of this site? Confirm its status
BudapestHungaryRecruiting
University of Pecs
Coordinator of this site? Confirm its status
PécsHungaryRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.