NCT06840509Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 18 Feb 2025
- Start date
- 23 Jul 2025
- Primary completion date
- 4 Dec 2025
- Lead sponsor
- Biotronik Australia Pty Ltd.
- Diseases
- Heart failure
- NCT number
- NCT06840509
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From 23 Jul 2025 to the primary completion date, 4 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
Age
- Age less than 18 years
Other
- For VR-T DX and CRT-DX: Permanent atrial tachyarrhythmia
- For VR-T DX and CRT-DX: Patients requiring atrial pacing
- Planned for His-Bundle-Pacing
- Pregnant or breast feeding
- Participation in another interventional clinical investigation according to the definition given below 2,3
- Life-expectancy less than 12 months
Who the study is looking for
- Standard indication for ICD or CRT-D therapy according to clinical guidelines
- Planned for de novo implantation of an ICD/CRT-D, or upgrade/exchange from existing ICD/CRT-D or pacemaker implant
- Ability to understand the nature of the study
- Willingness to provide written informed consent
- Ability and willingness to perform all on-site follow-up visits at the study site Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.