Observes routine care of patients with heart rhythm monitors
Follows people with heart rhythm problems who wear an implanted cardiac monitor.
Plain-language title generated from the registry record
Registry title: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Key facts
- Where
- Castrovillari and Torino, ItalySee the 2 sites
Where in Italy
- Ospedale Civile FerrariCastrovillari, ItalyTaking people
- Ospedale Maria VittoriaTorino, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biotronik SE & Co. KG
- Trial code
- NCT04075084
- Record updated
- 1 October 2025
- Original description
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.Read full original descriptionShow less
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
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.
Inclusion: 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: Patient is less than 18 years old; Patient is pregnant or breast feeding; Patient is participating in another interventional clinical investigation other than the submodules of BIO|STREAM.ICM.