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

March 5, 2026 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

151

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Standard indication for ICD or CRT-D

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CorSky-related SADE-d free rate at 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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