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

NCT06840509 | Active Not Recruiting

• 1 other identifier: TA120
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachycardia; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Serious adverse device effect (SADE)-free rate after 12 months

  Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate

  12 months

Study Arms (1)

Patients with indication for ICD or CRT-D therapy according to standard clinical guidelines.

EXPERIMENTAL

Device: CorSky ICD or CRT-D

Interventions

CorSky ICD or CRT-D DEVICE

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.

Patients with indication for ICD or CRT-D therapy according to standard clinical guidelines.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik Australia Pty Ltd.: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (1)

Princess Alexandra Hospital

Brisbane, Australia

Location

MeSH Terms

Conditions

Tachycardia; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: July 23, 2025
• Primary Completion: December 4, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-02

Locations

AU (1)