BIO|MASTER.CorSky Family Post-market Study for the CorSky Family of ICDs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorBiotronik SE & Co. KG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Standard indication for ICD or CRT-D
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
CorSky ICD or CRT-D
DeviceSubjects 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
CorSky-related SADE-d free rate at 6 months
CorSky-related SADE-d free rate at 6 months
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov