NCT04075084Recruiting
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Source: ClinicalTrials.gov · Last updated 1 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 8 Aug 2019
- Start date
- Oct 2019
- Primary completion date
- May 2027
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT04075084
What you commit to
- Study type: Observational
- Planned participants: 1400
- From Oct 2019 to the primary completion date, May 2027
- 31 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Patient is less than 18 years old.
Other
- Patient is pregnant or breast feeding.
- Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (31)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Integral Health Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| Royal Adelaide Hospital Coordinator of this site? Confirm its status | Adelaide | Australia | Completed |
| GZO Spital Wetzikon Coordinator of this site? Confirm its status | Wetzikon | Switzerland | Completed |
| Universitätsspital Zürich USZ Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Recruiting |
| St. Marienkrankhaus Klinikum Westmünsterland GmbH Coordinator of this site? Confirm its status | Ahaus | Germany | Recruiting |
| Kerckhoff-Klinik GmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Recruiting |
| Rhön-Klinikum Coordinator of this site? Confirm its status | Bad Neustadt an der Saale | Germany | Active, not recruiting |
| Universitätsklinik an der Technischen Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Helios Klinikum Erfurt Coordinator of this site? Confirm its status | Erfurt | Germany | Recruiting |
| Klinikum Herford Coordinator of this site? Confirm its status | Herford | Germany | Recruiting |
| Helios Health Institute GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Deutsches Herzzentrum der Charité Coordinator of this site? Confirm its status | Mitte | Germany | Recruiting |
| Klinikum rechts der Isar der Technischen Universität München Coordinator of this site? Confirm its status | München | Germany | Active, not recruiting |
| Deutsches Herzzentrum der Charité Coordinator of this site? Confirm its status | Steglitz | Germany | Recruiting |
| Centro Médico Teknon Coordinator of this site? Confirm its status | Erandio | Spain | Recruiting |
| Hospital de Fuenlabrada Coordinator of this site? Confirm its status | Fuenlabrada | Spain | Active, not recruiting |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Recruiting |
| Hospital Universitario de Araba Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Recruiting |
| Hôpital Saint-André Coordinator of this site? Confirm its status | Bordeaux | France | Completed |
| Le Centre Hospitalier Universitaire de Brest (CHRU Brest) Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Le Centre Hospitalier Universitaire de Caen (CHRU Caen) Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Le Centre Hospitalier Universitaire de Tours (CHRU Tours) Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Active, not recruiting |
| Hopital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Hopital Haut-Leveque - Chu Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Hopitaux Universitaires de Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Ospedale Civile Ferrari Coordinator of this site? Confirm its status | Castrovillari | Italy | Recruiting |
| Ospedale Maria Vittoria Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.