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Clinical Trial

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

NCT: NCT06840509 · ACTIVE_NOT_RECRUITING

NCT IDNCT06840509
StatusACTIVE_NOT_RECRUITING
Start Date2025-07-23
Completion2026-12
SponsorBiotronik Australia Pty Ltd. (INDUSTRY)
First posted
Last updated

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.

Frequently Asked Questions

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

BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family is a clinical trial registered under NCT06840509. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT06840509?

The current status of NCT06840509 (BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family) is: ACTIVE_NOT_RECRUITING.

When did BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family start?

BIO|CONCEPT.CorSky, First in Human Study for the CorSky ICD Family started on 2025-07-23.

Related Devices

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.