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BIO|CONCEPT.CorSky Family, 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Princess Alexandra Hospital
Brisbane, Australia
Start Date
July 23, 2025
Primary Completion Date
December 4, 2025
Completion Date
December 1, 2026
Last Updated
February 17, 2026
52
ACTUAL participants
CorSky ICD or CRT-D
DEVICE
Lead Sponsor
Biotronik Australia Pty Ltd.
Collaborators
NCT07191730
NCT07484009
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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