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RecruitingNCT07360158Updated Jul 10, 2026

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

An observational study in Tachyarrhythmia and Heart Failure, sponsored by Biotronik SE & Co. KG. Recruiting at 7 sites in 4 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Biotronik SE & Co. KG · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
151
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tachyarrhythmia
  • Heart Failure
03

In context

Tachycardia

189 studies on the registry are indexed under Tachycardia; 24 are open to participants now.

This study's planned enrollment of 151 is below the median of 200 across 62 observational studies indexed under Tachycardia.

Browse Tachycardia studies →

Lead sponsor

Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.

Browse Biotronik SE & Co. KG studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Standard indication for ICD or CRT-D

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
151 participants (estimated)
Patient registry
No

Interventions

  • DeviceCorSky ICD or CRT-D

    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.

06

What researchers measure

Primary outcomes

  1. CorSky-related SADE-d free rate at 6 months

    CorSky-related SADE-d free rate at 6 months

    Time frame: 6 months

07

Study locations

7 of 7 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.

Of 27 observational studies under Tachycardia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2026
First posted
Jan 22, 2026
StartActual
Jun 22, 2026
Primary completionEst.
May 2027
CompletionEst.
May 2028
Last update
Jul 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07360158
Lead sponsor
Biotronik SE & Co. KG
Responsible party
Sponsor
First posted
Jan 22, 2026
Start date
Jun 22, 2026
Primary completion
May 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Jul 10, 2026

Study contacts

Anja Viehrig, Dr. rer. nat.
Contact
anja.viehrig@biotronik.com
+49(0)1516890-1304
Konstantinia Skreka, Dr. rer. nat.
Contact
konstantinia.skreka@biotronik.com
030-68905 2949
Alan Bulava, MD, PhD, Prof. Dr.
study chair · Fakultní nemocnice Olomouc, CZE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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