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

NCT ID: NCT06840509

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-23
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Tachycardia; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with indication for ICD or CRT-D therapy according to standard clinical guidelines.

Group Type: EXPERIMENTAL

CorSky ICD or CRT-D

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: collaborator

Biotronik Australia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princess Alexandra Hospital

Brisbane, , Australia

Site Status: RECRUITING

Countries

Australia

Facility Contacts

Paul Gould, A/Prof

Role: primary

paul.gould@health.qld.gov.au

07 3176 6318

Other Identifiers

TA120

Identifier Type: -

Identifier Source: org_study_id