U.S., Feb. 22 -- ClinicalTrials.gov registry received information related to the study (NCT06840509) titled 'BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family' on Feb. 18.
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 measu...