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

Launched by BIOTRONIK AUSTRALIA PTY LTD. · Feb 18, 2025

Keywords

ClinConnect Summary

The BIO|CONCEPT.CorSky trial is a new study that aims to test a device called the CorSky ICD family, which is designed to help people with heart conditions, specifically those who experience fast heartbeats (tachycardia) or heart failure. The study will take place in Australia and New Zealand and will involve 50 participants who need an implantable cardioverter-defibrillator (ICD) or a special device called cardiac resynchronization therapy-defibrillator (CRT-D). If you qualify for this study, you will have a series of visits for check-ups, including before and after the device is implanted, to ensure everything is working well.

To be eligible for this trial, participants should be between 18 and 74 years old and have a medical need for an ICD or CRT-D according to standard guidelines. You must be able to understand the study, agree to participate by signing a consent form, and attend all follow-up visits. However, some people may not qualify, such as those with certain heart conditions, those who are pregnant or breastfeeding, or those who have a life expectancy of less than 12 months. This study is important as it helps researchers learn more about the safety and performance of this new device, which could improve treatment options for patients with heart problems in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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
• • Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
• • Pregnant or breast feeding
• • Age less than 18 years
• • Participation in another interventional clinical investigation according to the definition given below 2,3
• • Life-expectancy less than 12 months