CorSky ICD/CRT-D Family Post-market Experience

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational post-market study evaluating the CorSky family of implantable cardioverter-defibrillators and CRT-D devices. It collects safety and performance data from adults undergoing de novo implantation or upgrade/exchange, with follow-up visits at the study sites. The study leverages existing BIOTRONIK features and integrates with the Amvia pacemaker family where applicable, including CardioMessenger and BIOTRONIK Home Monitoring. Participation requires adherence to follow-up schedules and understanding of the device and study concepts. Key exclusion criteria include certain arrhythmias, planned His-bundle pacing, pregnancy, age under 18, and limited life expectancy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Medizinische Universität Graz
  Graz, Styria, Austria Recruiting
• Fakultní nemocnice u sv. Anny v Brně
  Brno, Czechia Recruiting
• Nemocnice Ceske Budejovice, a.s.
  České Budějovice, Czechia Recruiting
• Universitätsklinikum Würzburg
  Würzburg, Bavaria, Germany Recruiting
• SRH Wald-Klinikum Gera GmbH
  Gera, Thuringia, Germany Recruiting
• Semmelweis University
  Budapest, Hungary Recruiting

Study contacts

• Study coordinator: Anja Viehrig, Dr. rer. nat.
• Email: anja.viehrig@biotronik.com
• Phone: +49(0)1516890-1304

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.