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Heart monitor study tracks Real-World performance

NCT ID NCT04075084

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 1,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

atrial fibrillation Bradycardia Ischemic Stroke Syncope syncope, familial vasovagal Tachycardia

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.

  1. The places running it

    23 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centro Médico Teknon

    RECRUITING

    Erandio, Spain

  • Deutsches Herzzentrum der Charité

    RECRUITING

    Mitte, Germany

  • Deutsches Herzzentrum der Charité

    RECRUITING

    Steglitz, Germany

  • GZO Spital Wetzikon

    COMPLETED

    Wetzikon, Switzerland

  • Helios Health Institute GmbH

    RECRUITING

    Leipzig, Germany

  • Helios Klinikum Erfurt

    RECRUITING

    Erfurt, Germany

  • Hospital Universitario de Araba

    RECRUITING

    Vitoria-Gasteiz, Spain

  • Hospital de Fuenlabrada

    ACTIVE_NOT_RECRUITING

    Fuenlabrada, Spain

  • Hospital Álvaro Cunqueiro

    RECRUITING

    Vigo, Spain

  • Hôpital Gabriel Montpied

    RECRUITING

    Clermont-Ferrand, France

  • Hôpital Haut Lévêque (CHU)

    RECRUITING

    Pessac, France

  • Hôpital Saint-André

    COMPLETED

    Bordeaux, France

  • Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, France

  • Integral Health

    RECRUITING

    Adelaide, Australia

  • Kerckhoff-Klinik GmbH

    RECRUITING

    Bad Nauheim, Germany

  • Klinikum Herford

    RECRUITING

    Herford, Germany

  • Klinikum rechts der Isar der Technischen Universität München

    ACTIVE_NOT_RECRUITING

    München, Germany

  • Le Centre Hospitalier Universitaire de Brest (CHRU Brest)

    RECRUITING

    Brest, France

  • Le Centre Hospitalier Universitaire de Caen (CHRU Caen)

    RECRUITING

    Caen, France

  • Le Centre Hospitalier Universitaire de Tours (CHRU Tours)

    ACTIVE_NOT_RECRUITING

    Chambray-lès-Tours, France

  • Nemocnice Ceske Budejovice, a.s.

    RECRUITING

    České Budějovice, 37001, Czechia

  • Ospedale Civile Ferrari

    RECRUITING

    Castrovillari, Italy

  • Ospedale Maria Vittoria

    RECRUITING

    Torino, Italy

  • Pauls Stradins Clinical University Hospital

    RECRUITING

    Riga, 1002, Latvia

  • Rhön-Klinikum

    ACTIVE_NOT_RECRUITING

    Bad Neustadt an der Saale, Germany

  • Royal Adelaide Hospital

    COMPLETED

    Adelaide, Australia

  • St. Marienkrankhaus Klinikum Westmünsterland GmbH

    RECRUITING

    Ahaus, Germany

  • Unidade Local de Saúde de Santa Maria, E. P. E.

    RECRUITING

    Lisbon, Portugal

  • Unidade Local de Saúde do Alto Ave, E. P. E.

    RECRUITING

    Guimarães, Portugal

  • Universitätsklinik an der Technischen Universität Dresden

    COMPLETED

    Dresden, Germany

  • Universitätsspital Zürich (USZ)

    RECRUITING

    Zurich, Switzerland

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Other studies related to the condition(s) this trial covers.