BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs

Biotronik

Status: Begins enrollment in 3 months

Conditions: Tachycardia, Heart Failure

Treatments: Device: CorSky ICD or CRT-D

Study type: Observational

Funder types: Industry

Identifiers

NCT07360158

TA121

Details and patient eligibility

About

The CorSky family is BIOTRONIK´s new generation of ICDs. They are the successor devices of the current Acticor/Rivacor family and inherit all iShock/iShock_BC (Ilivia Neo, Intica Neo) implant and programmer software features.

The new features of CorSky Family are either true novel BIOTRONIK ICD features or mainly driven by unification with the Amvia pacemaker family (Amvia Edge, -Sky).

The goal of the study is to confirm the safety and performance of the CorSky Family of ICDs and CRT-Ds.

Enrollment: 151 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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
• Ability to understand the nature of the study.
• 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 an interventional clinical investigation in parallel to this study. ,
• Life-expectancy less than 12 months.