TachycardiaBIOSTREAM-ICMNCT04075084
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
An observational study of Tachycardia and Atrial Fibrillation, run by Biotronik SE & Co. KG at 31 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Atrial Fibrillation, Syncope
- How many people
- 1,400 participants
- Where
- 31 sitesin 9 countries
- Study dates
- 28 Oct 2019to 30 Aug 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
Who may be able to join
- 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 join
- 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
Trial locations and contacts
31 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 9 countries
Germany10 sites, 7 recruiting
- Recruiting
St. Marienkrankhaus Klinikum Westmünsterland GmbH
Ahaus
Alessandro Cueno, Dr.
- Recruiting
Kerckhoff-Klinik GmbH
Bad Nauheim
Andreas Hain, Dr.
- Active, not recruiting
Rhön-Klinikum
Bad Neustadt an der Saale
- Completed
Universitätsklinik an der Technischen Universität Dresden
Dresden
- Recruiting
Helios Klinikum Erfurt
Erfurt
Frank Steinborn, Dr.
- Recruiting
Klinikum Herford
Herford
Jan Kähler, Prof. Dr.
- Recruiting
Helios Health Institute GmbH
Leipzig
Sotirios Nedios, Dr.
- Recruiting
Deutsches Herzzentrum der Charité
Mitte
Verena Tscholl, Dr.
- Active, not recruiting
Klinikum rechts der Isar der Technischen Universität München
München
- Recruiting
Deutsches Herzzentrum der Charité
Steglitz
Patrick Nagel, Dr.
France7 sites, 5 recruiting
- Completed
Hôpital Saint-André
Bordeaux
- Recruiting
Le Centre Hospitalier Universitaire de Brest (CHRU Brest)
Brest
Jacques Mansourati, Pr.
- Recruiting
Le Centre Hospitalier Universitaire de Caen (CHRU Caen)
Caen
Virgine Ferchaud, Dr
- Active, not recruiting
Le Centre Hospitalier Universitaire de Tours (CHRU Tours)
Chambray-lès-Tours
- Recruiting
Hôpital Gabriel Montpied
Clermont-Ferrand
Romain Eschalier, Pr.
- Recruiting
Hôpital Haut Lévêque (CHU)
Pessac
Sylvain Ploux, Pr.
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg
Laurence Jesel-Morel, Dr.
Spain4 sites, 3 recruiting
- Recruiting
Centro Médico Teknon
Erandio
Antonio Berruezo Sanchez, Dr.
- Active, not recruiting
Hospital de Fuenlabrada
Fuenlabrada
- Recruiting
Hospital Álvaro Cunqueiro
Vigo
Pilar Cabanas, Dr.
- Recruiting
Hospital Universitario de Araba
Vitoria-Gasteiz
Enrique Garcia, Dr.
Australia2 sites, 1 recruiting
- Recruiting
Integral Health
Adelaide
Dennis Lau, Dr.
- Completed
Royal Adelaide Hospital
Adelaide
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Civile Ferrari
Castrovillari
Giovanni Bisignani, Dr.
- Recruiting
Ospedale Maria Vittoria
Torino
Massimo Giammaria, Dr.
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saúde do Alto Ave, E. P. E.
Guimarães
Victor M. Sanfins, Dr.
- Recruiting
Unidade Local de Saúde de Santa Maria, E. P. E.
Lisbon
João de Sousa, Dr.
Switzerland2 sites, 1 recruiting
- Completed
GZO Spital Wetzikon
Wetzikon
- Recruiting
Universitätsspital Zürich (USZ)
Zurich
Daniel Hofer, Dr.
Czechia1 site, 1 recruiting
- Recruiting
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 37001
Alan Bulava, Prof.
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga, 1002
Andrejs Erglis, Prof
About this study
Official title: 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.
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia, Cryptogenic Stroke
- Keywords
- Implantable Cardiac Monitor, BIOMONITOR III, BIOMONITOR IV
- Medical subject headings
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
Measured: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Secondary outcomes (1)
Insertion procedure and success
Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions.
Measured: Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start28 Oct 2019
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075084
- Sponsor's protocol ID
- HS061
- Acronym
- BIOSTREAM-ICM
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2019
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.
PubMed 37025684
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
- ClinicalTrials.gov ID
- NCT04075084
- Acronym / sponsor ID
- BIOSTREAM-ICM / HS061
- Conditions
- Tachycardia, Atrial Fibrillation, Syncope, Bradycardia, Cryptogenic Stroke
- Keywords
- Implantable Cardiac Monitor, BIOMONITOR III, BIOMONITOR IV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to diagnosis
Time frame: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
1 secondary outcome
Insertion procedure and success
Time frame: Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 37025684Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachycardia and Atrial Fibrillation, run by Biotronik SE & Co. KG at 31 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, France, Spain, Australia, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Hoche, Dr. (+49 30 68905 ext. 1337, biomonitor-registry@biotronik.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to diagnosis (time frame: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.