ATRIAL FIBRILLATION, SyncopeBioMonitorNCT01725568
BioMonitor Master Study
An observational study of ATRIAL FIBRILLATION, Syncope, run by Biotronik SE & Co. KG at 1 site in Germany.
Trial summary
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATRIAL FIBRILLATION, Syncope
- What is being tested?
- BioMonitor
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Oct 2014
- 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 with standard ICM indication who are referred to the hospital
Who may be able to join
- Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.
Who cannot join
- Implanted ICD or cardiac pacemaker
- Allergy to patch electrodes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Master Study of the Implantable Cardiac Monitor "BioMonitor"
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.
- Conditions
- ATRIAL FIBRILLATION, Syncope
- Being tested
- BioMonitor
- Medical subject headings
- Atrial Fibrillation, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMonitorDevice
Implantable cardiac monitor
| Study group | Role | What they receive |
|---|---|---|
| Implantable cardiac monitor diagnostics | Patients has standard indication for implantable cardiac monitor diagnostic. Receives: Device: BioMonitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
SADE free-rate
SADE free-rate > 90% at 3 month follow-up
Measured: at 3 month follow-up
Rate of appropriate QRS detection
Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording)
Measured: at 6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATRIAL FIBRILLATION, 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dietmar Baensch, Professor, Principal investigator, University of Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725568
- Sponsor's protocol ID
- 60
- Acronym
- BioMonitor
- Status last verified
- Nov 2014
- First submitted
- 6 Nov 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Study of the Implantable Cardiac Monitor "BioMonitor"
- ClinicalTrials.gov ID
- NCT01725568
- Acronym / sponsor ID
- BioMonitor / 60
- Conditions
- ATRIAL FIBRILLATION, Syncope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Nov 2012 (estimated)
- 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 BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implantable cardiac monitor diagnostics | – | Device: BioMonitorPatients has standard indication for implantable cardiac monitor diagnostic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with standard ICM indication who are referred to the hospital
Key inclusion criteria (1 listed)
- Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin.
Key exclusion criteria (2 listed)
- Implanted ICD or cardiac pacemaker
- Allergy to patch electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMonitorImplantable cardiac monitor | Device | Implantable cardiac monitor diagnostics |
Primary outcome
SADE free-rate
Time frame: at 3 month follow-up
SADE free-rate > 90% at 3 month follow-up
Rate of appropriate QRS detection
Time frame: at 6 week follow-up
Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording)
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 20 Nov 2014.
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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. This study is not recruiting at the moment.
Dietmar Baensch, Professor principal investigator
University of Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ATRIAL FIBRILLATION, Syncope, run by Biotronik SE & Co. KG at 1 site in Germany.
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 1 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 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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: at 3 month follow-up). The study lists 2 primary outcomes in all. 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 20 Nov 2014; AzTrials last refreshed its copy on 27 Oct 2026.