NCT06840509

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Biotronik Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-07-23
• Primary completion: 2025-12-04
• Completion: 2026-12-01
• First posted: 2025-02-21
• Last updated: 2026-02-17

Locations

1 site across 1 country: Australia