SyncopeNCT04206774
BIO|STREAM.ICM France
An observational study of Syncope and Cryptogenic Stroke, run by Biotronik SE & Co. KG at 3 sites in France.
Trial summary
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Cryptogenic Stroke
- How many people
- 92 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Mar 2020to 16 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients treated in French investigation sites, with an indication for Insertable Cardiac Monitors (ICM) in accordance with the European guidelines and followed with the BIOTRONIK Home Monitoring® system.
Who may be able to join
- Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
- Enrolled in the BIO|STREAM.ICM registry
Who cannot join
- Life-expectancy is less than 3 months
- Already implanted with BIOMONITOR
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Gabriel Montpied
Clermont-Ferrand, Caen, 14000
CH Villefranche Sur Saone
Gleizé
CHRU de Tours, Hopital Trousseau
Tours, 37044
About this study
Official title: BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system
Read the detailed description
The BIO|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.
- Conditions
- Syncope, Cryptogenic Stroke
- Medical subject headings
- Syncope, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
SADE free rate
Serious adverse device effect (SADE) free rate related to the BIOMONITOR system
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start13 Mar 2020
- Primary completion1 Jul 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Romain ESCHALIER, Pr., Principal investigator, Hôpital Gabriel Montpied
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206774
- Sponsor's protocol ID
- HS066
- Status last verified
- Jan 2022
- First submitted
- 12 Dec 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry
- ClinicalTrials.gov ID
- NCT04206774
- Acronym / sponsor ID
- HS066
- Conditions
- Syncope, Cryptogenic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 20 Dec 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.
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system
Detailed description
The BIO|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in French investigation sites, with an indication for Insertable Cardiac Monitors (ICM) in accordance with the European guidelines and followed with the BIOTRONIK Home Monitoring® system.
Key inclusion criteria (2 listed)
- Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia
- Enrolled in the BIO|STREAM.ICM registry
Key exclusion criteria (2 listed)
- Life-expectancy is less than 3 months
- Already implanted with BIOMONITOR
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
SADE free rate
Time frame: 3 month
Serious adverse device effect (SADE) free rate related to the BIOMONITOR system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Syncope
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Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
Orthostatic Hypotension, Reflex Syncope
Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
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RecruitingObservational study
Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Arrhythmias, Cardiac
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. This study is not recruiting at the moment.
Romain ESCHALIER, Pr. principal investigator
Hôpital Gabriel Montpied
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Cryptogenic Stroke, run by Biotronik SE & Co. KG at 3 sites in France.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SADE free rate (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2022.