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

NCT07360158 · tracked via the Priya Life Science Germany tracker

Sponsor

Biotronik SE & Co. KG

Phase

Observational

Started

2026-06-22

Last updated

2026-07-10

Condition(s) studied

TachyarrhythmiaHeart Failure

Investigational drug(s) / intervention(s)

CorSky ICD or CRT-D

CorSky 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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (7)

Facility	City	Region	Status
Medizinische Universität Graz	Graz	Styria	Recruiting
Fakultní nemocnice u sv. Anny v Brně	Brno	Czechia	Recruiting
Nemocnice Ceske Budejovice, a.s.	České Budějovice	Czechia	Recruiting
Universitätsklinikum Würzburg	Würzburg	Bavaria	Recruiting
SRH Wald-Klinikum Gera GmbH	Gera	Thuringia	Recruiting
Semmelweis University	Budapest	Hungary	Recruiting
University of Pécs	Pécs	Hungary	Recruiting

More Biotronik SE & Co. KG trials in Germany

Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products Recruiting

BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software Recruiting

BIO|STREAM.CSP Study Recruiting

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs) Recruiting

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07360158 on ClinicalTrials.gov ↗ ← All trials in Germany