Observing patients with BIOTRONIK Implantable Cardiac Monitors

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 registry aims to assess the long-term outcomes, performance, and safety of the BIOMONITOR III and its successors in a real-world clinical setting. It is designed to facilitate additional scientific and regulatory investigations while minimizing the burden on patients and investigational sites. The study will collect data on patients receiving these cardiac monitors to better understand their effectiveness and safety over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM)
* Patient is able to understand the nature of the registry and to provide written informed consent.
* Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.

Exclusion Criteria:

* Patient is pregnant or breast feeding.
* Patient is less than 18 years old.
* Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM

Where it's running

• Integral Health
  Adelaide, Australia Recruiting
• Nemocnice Ceske Budejovice, a.s.
  České Budějovice, Czechia Recruiting
• Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
  Brest, France Recruiting
• Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
  Caen, France Recruiting
• Hôpital Gabriel Montpied
  Clermont-Ferrand, France Recruiting
• Hôpital Haut Lévêque (CHU)
  Pessac, France Recruiting

Study contacts

• Study coordinator: Sabrina Hoche, Dr.
• Email: biomonitor-registry@biotronik.com
• Phone: +49 30 68905

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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.