Observes routine care of patients with heart rhythm monitors
Follows people with heart rhythm problems who wear an implanted cardiac monitor.
Key facts
- Who runs it
- Biotronik SE & Co. KG
- Where
- Bordeaux, Brest, Caen, Chambray-lès-Tours, Clermont-Ferrand, Pessac, and Strasbourg, FranceSee the 7 sitesAlso in 8 other countries, 24 sites
- Trial code
- Registry title
- Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
- Status
- Recruiting
- People taking part
- 1,400 people, planned
- Started
- 28 Oct 2019
- Expected to end
- 30 Aug 2027
- Type of study
- Observational
- Record updated
- 1 October 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The registry is looking for adults who are going to receive a BIOTRONIK implantable cardiac monitor (ICM) and who can use the CardioMessenger and BIOTRONIK Home Monitoring.
- Age
- 18 years or older
- Sex
- Women and men can join
Main reasons for not taking part
- Pregnant or breast feeding
- Younger than 18 years
- Taking part in another interventional clinical investigation (the submodules of BIO|STREAM.ICM are the exception)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
Also in 8 other countries, 24 sites
- Hôpital Saint-AndréBordeaux, FranceContact: Sabrina Hoche, Dr.No longer taking part
- Le Centre Hospitalier Universitaire de Brest (CHRU Brest)Brest, FranceContact: Jacques Mansourati, Pr.Taking people
- Le Centre Hospitalier Universitaire de Caen (CHRU Caen)Caen, FranceContact: Virgine Ferchaud, DrTaking people
- Le Centre Hospitalier Universitaire de Tours (CHRU Tours)Chambray-lès-Tours, FranceContact: Sabrina Hoche, Dr.No longer taking part
- Hopital Gabriel MontpiedClermont-Ferrand, FranceContact: Romain Eschalier, Pr.Taking people
- Hopital Haut-Leveque - ChuPessac, FranceContact: Sylvain Ploux, Pr.Taking people
- Hopitaux Universitaires de StrasbourgStrasbourg, FranceContact: Laurence Jesel-Morel, Dr.Taking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
- Plain-language title
- Observes routine care of patients with heart rhythm monitorsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 October 2025