Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik SE & Co. KG
About this trial
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
31Australia
Integral Health Adelaide Australia
Royal Adelaide Hospital Adelaide Australia
Czechia
Nemocnice Ceske Budejovice, a.s.37001, České Budějovice Czechia
France
Hôpital Saint-André Bordeaux France
Sponsors and collaborators
Biotronik SE & Co. KG
Lead sponsor
Source ClinicalTrials.gov