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BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family
Sponsor: Biotronik Australia Pty Ltd.
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.
Official title: BIO|CONCEPT.CorSky Family, First in Human Study for the CorSky ICD Family
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2025-07-23
Completion Date
2026-12
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
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.
Locations (1)
Princess Alexandra Hospital
Brisbane, Australia