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

NCT07360158 | Recruiting

• 1 other identifier: TA121
• Study Type: observational
• Target: 151
• Locations: 4 countries
• Sites: 7

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.

Conditions

Tachyarrhythmia; Heart Failure

Outcome Measures

Primary Outcomes (1)

• CorSky-related SADE-d free rate at 6 months

  CorSky-related SADE-d free rate at 6 months

  6 months

Interventions

CorSky ICD or CRT-D DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Standard indication for ICD or CRT-D

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (7)

Medizinische Universität Graz

Graz, Styria, 8010, Austria

RECRUITING

Fakultní nemocnice u sv. Anny v Brně

Brno, CZ-65691, Czechia

RECRUITING

Nemocnice Ceske Budejovice, a.s.

České Budějovice, 37001, Czechia

RECRUITING

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

SRH Wald-Klinikum Gera GmbH

Gera, Thuringia, 07548, Germany

RECRUITING

Semmelweis University

Budapest, 1122, Hungary

RECRUITING

University of Pécs

Pécs, H-7624, Hungary

RECRUITING

MeSH Terms

Conditions

Tachycardia; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Bulava, MD, PhD, Prof. Dr.

  Fakultní nemocnice Olomouc, CZE

  STUDY CHAIR

Central Study Contacts

Anja Viehrig, Dr. rer. nat.

CONTACT

+49(0)1516890-1304; anja.viehrig@biotronik.com

Konstantinia Skreka, Dr. rer. nat.

CONTACT

030-68905 2949; konstantinia.skreka@biotronik.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-01

Locations

CZ (2); DE (2); AU (1); HU (2)