Heart monitor study tracks Real-World performance
NCT ID NCT04075084
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study watches how well a small heart monitor (BIOMONITOR III) works in routine medical care for 1400 people. It tracks how quickly the device finds hidden heart rhythm problems like atrial fibrillation or fainting spells. The goal is to learn about the device's real-life performance and safety, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
23 sites in 9 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centro Médico Teknon
RECRUITINGErandio, Spain
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Deutsches Herzzentrum der Charité
RECRUITINGMitte, Germany
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Deutsches Herzzentrum der Charité
RECRUITINGSteglitz, Germany
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GZO Spital Wetzikon
COMPLETEDWetzikon, Switzerland
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Helios Health Institute GmbH
RECRUITINGLeipzig, Germany
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Helios Klinikum Erfurt
RECRUITINGErfurt, Germany
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Hospital Universitario de Araba
RECRUITINGVitoria-Gasteiz, Spain
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Hospital de Fuenlabrada
ACTIVE_NOT_RECRUITINGFuenlabrada, Spain
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Hospital Álvaro Cunqueiro
RECRUITINGVigo, Spain
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Hôpital Gabriel Montpied
RECRUITINGClermont-Ferrand, France
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Hôpital Haut Lévêque (CHU)
RECRUITINGPessac, France
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Hôpital Saint-André
COMPLETEDBordeaux, France
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Hôpitaux Universitaires de Strasbourg
RECRUITINGStrasbourg, France
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Integral Health
RECRUITINGAdelaide, Australia
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Kerckhoff-Klinik GmbH
RECRUITINGBad Nauheim, Germany
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Klinikum Herford
RECRUITINGHerford, Germany
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Klinikum rechts der Isar der Technischen Universität München
ACTIVE_NOT_RECRUITINGMünchen, Germany
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Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
RECRUITINGBrest, France
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Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
RECRUITINGCaen, France
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Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
ACTIVE_NOT_RECRUITINGChambray-lès-Tours, France
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Nemocnice Ceske Budejovice, a.s.
RECRUITINGČeské Budějovice, 37001, Czechia
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Ospedale Civile Ferrari
RECRUITINGCastrovillari, Italy
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Ospedale Maria Vittoria
RECRUITINGTorino, Italy
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Pauls Stradins Clinical University Hospital
RECRUITINGRiga, 1002, Latvia
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Rhön-Klinikum
ACTIVE_NOT_RECRUITINGBad Neustadt an der Saale, Germany
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Royal Adelaide Hospital
COMPLETEDAdelaide, Australia
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St. Marienkrankhaus Klinikum Westmünsterland GmbH
RECRUITINGAhaus, Germany
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Unidade Local de Saúde de Santa Maria, E. P. E.
RECRUITINGLisbon, Portugal
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Unidade Local de Saúde do Alto Ave, E. P. E.
RECRUITINGGuimarães, Portugal
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Universitätsklinik an der Technischen Universität Dresden
COMPLETEDDresden, Germany
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Universitätsspital Zürich (USZ)
RECRUITINGZurich, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation
- Suture device may get heart patients walking sooner after leg vein procedures
- Two ways to catch a hidden heart rhythm after stroke
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?