BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family

The goal of this exploratory study is to test the preliminary safety and product performance of the new CorSky ICD family in subjects that require an ICD or cardiac resynchronization therapy with defibrillation (CRT-D). The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the ICDs will be done according to the participant´s therapeutical needs.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Alexandra Hospital

Brisbane, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 implant
Ability to understand the nature of the study
Willingness to provide written informed consent
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 another interventional clinical investigation according to the definition given below 2,3
Life-expectancy less than 12 months

Treatment and study plan

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.

Primary outcomes

Serious adverse device effect (SADE)-free rate after 12 months

Time frame: 12 months

Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate

Sponsors and collaborators

Lead sponsor

Biotronik Australia Pty Ltd.

Industry

Collaborators

Biotronik SE & Co. KG

Registry information

Official study title

BIO|CONCEPT.CorSky Family, First in Human Study for the CorSky ICD Family

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Feb 21, 2025
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting