Atrial FibrillationBAYathlonNCT02875106
A Digital Non-interventional Atrial Fibrillation (AF) Screening Study With Commercial Pulse Detection Systems
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Germany.
Trial summary
The primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus rhythm of screened patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 12-point-ECG, Polar V800 and 360° eMotion FAROS SET + Belt
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2017to 8 May 2019
- 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 for whom the decision to record an ECG was made as per investigator's routine treatment practice
Who may be able to join
- Adult female and male patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
- Patient able and willing to provide signed informed consent
Who cannot join
- Patients with any comorbidities or abnormalities of heart function or rhythm, which might, in the opinion of the investigator, interfere with the evaluation of study data
- Patients participating in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BAYathlon - a Digital Non-interventional AF Screening Study to Identify Commercial Pulse Detection Systems (CPDS) Detecting AF and Sinus Rhythm Parallel to ECG Recording Within Routine Clinical Setting
The primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus rhythm of screened patients.
- Conditions
- Atrial Fibrillation
- Being tested
- 12-point-ECG, Polar V800, 360° eMotion FAROS SET + Belt, Adidas Micoach smart run, TomTom Runner Cardio HRM
- Keywords
- Sinus rhythm
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-point-ECGDevice
routine recording will be 300 seconds
Polar V800Device
routine recording will be 300 seconds
360° eMotion FAROS SET + BeltDevice
routine recording will be 300 seconds
Adidas Micoach smart runDevice
routine recording will be 300 seconds
TomTom Runner Cardio HRMDevice
routine recording will be 300 seconds
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation Patients | Adult female and male patients with diagnosed atrial fibrillation Receives: Device: 12-point-ECG; Device: Polar V800; Device: 360° eMotion FAROS SET + Belt; Device: Adidas Micoach smart run; Device: TomTom Runner Cardio HRM | |
| Sinus Rhythm Patients | Adult female and male patients with diagnosed sinus rhythm Receives: Device: 12-point-ECG; Device: Polar V800; Device: 360° eMotion FAROS SET + Belt; Device: Adidas Micoach smart run; Device: TomTom Runner Cardio HRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
This will be calculated as proportion of patients with atrial fibrillation diagnosed by CPDS record out of the total number of patients diagnosed with atrial fibrillation by ECG record (for patients with diagnosis for both recordings available).
Measured: 120 seconds
Secondary outcomes (3)
The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS).
This will be calculated as proportion of patients with sinus rhythm diagnosed by CPDS record out of the total number of patients diagnosed with sinus rhythm by ECG record (for patients with diagnosis for both recordings available).
Measured: 120 seconds
The rate of correctly detected AF of the applied algorithm of the ECG-data in reference to the primary diagnosis of the investigator using the ECG-graph (sensitivity of algorithm).
This will be calculated as proportion of AF patients detected by the applied algorithm compared with proportion of AF patients diagnosed by the investigator, both based on ECG records.
Measured: 120 seconds
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
This will be a sensitivity analysis of derived sensitivities of CPDS in different time frames, calculated as proportion of patients with sinus rhythm diagnosed by CPDS record out of the total number of patients diagnosed with sinus rhythm by ECG record (for patients with diagnosis for both recordings available).
Measured: 60 seconds, 180 seconds, 240 seconds, 300 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start8 Nov 2017
- Primary completion5 Apr 2019
- Study completion8 May 2019
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 Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875106
- Sponsor's protocol ID
- 18796
- Acronym
- BAYathlon
- Status last verified
- May 2020
- First submitted
- 18 Aug 2016
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Muller C, Hengstmann U, Fuchs M, Kirchner M, Kleinjung F, Mathis H, Martin S, Blase I, Perings S. Distinguishing atrial fibrillation from sinus rhythm using commercial pulse detection systems: The non-interventional BAYathlon study. Digit Health. 2021 May 22;7:20552076211019620. doi: 10.1177/20552076211019620. eCollection 2021 Jan-Dec.
PubMed 34104466
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BAYathlon - a Digital Non-interventional AF Screening Study to Identify Commercial Pulse Detection Systems (CPDS) Detecting AF and Sinus Rhythm Parallel to ECG Recording Within Routine Clinical Setting
- ClinicalTrials.gov ID
- NCT02875106
- Acronym / sponsor ID
- BAYathlon / 18796
- Conditions
- Atrial Fibrillation
- Keywords
- Sinus rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 8 May 2019 (actual)
- First posted
- 23 Aug 2016 (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 primary objective in this study is to identify commercial pulse detection systems (CPDS) parallel to electrocardiogram (ECG) recording within routine clinical setting, which are able to detect atrial fibrillation or sinus rhythm of screened patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation Patients | – | Device: 12-point-ECG, Device: Polar V800, Device: 360° eMotion FAROS SET + Belt, Device: Adidas Micoach smart run, Device: TomTom Runner Cardio HRMAdult female and male patients with diagnosed atrial fibrillation |
| Sinus Rhythm Patients | – | Device: 12-point-ECG, Device: Polar V800, Device: 360° eMotion FAROS SET + Belt, Device: Adidas Micoach smart run, Device: TomTom Runner Cardio HRMAdult female and male patients with diagnosed sinus rhythm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
Key inclusion criteria (2 listed)
- Adult female and male patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
- Patient able and willing to provide signed informed consent
Key exclusion criteria (2 listed)
- Patients with any comorbidities or abnormalities of heart function or rhythm, which might, in the opinion of the investigator, interfere with the evaluation of study data
- Patients participating in an investigational program with interventions outside of routine clinical practice
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 |
|---|---|---|
| 12-point-ECGroutine recording will be 300 seconds | Device | Atrial Fibrillation Patients, Sinus Rhythm Patients |
| Polar V800routine recording will be 300 seconds | Device | Atrial Fibrillation Patients, Sinus Rhythm Patients |
| 360° eMotion FAROS SET + Beltroutine recording will be 300 seconds | Device | Atrial Fibrillation Patients, Sinus Rhythm Patients |
| Adidas Micoach smart runroutine recording will be 300 seconds | Device | Atrial Fibrillation Patients, Sinus Rhythm Patients |
| TomTom Runner Cardio HRMroutine recording will be 300 seconds | Device | Atrial Fibrillation Patients, Sinus Rhythm Patients |
Primary outcome
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
Time frame: 120 seconds
This will be calculated as proportion of patients with atrial fibrillation diagnosed by CPDS record out of the total number of patients diagnosed with atrial fibrillation by ECG record (for patients with diagnosis for both recordings available).
3 secondary outcomes
The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS).
Time frame: 120 seconds
The rate of correctly detected AF of the applied algorithm of the ECG-data in reference to the primary diagnosis of the investigator using the ECG-graph (sensitivity of algorithm).
Time frame: 120 seconds
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
Time frame: 60 seconds, 180 seconds, 240 seconds, 300 seconds
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 8 May 2020.
- Derived from this study: PubMed 34104466Muller C, Hengstmann U, Fuchs M, Kirchner M, Kleinjung F, Mathis H, Martin S, Blase I, Perings S. Distinguishing atrial fibrillation from sinus rhythm using commercial pulse detection systems: The non-interventional BAYathlon study. Digit Health. 2021 May 22;7:20552076211019620. doi: 10.1177/20552076211019620. eCollection 2021 Jan-Dec.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
Bayer Study Director study director
Bayer
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, run by Bayer 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 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 8 May 2020. 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?
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS). (time frame: 120 seconds). 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 NCT02875106, 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 8 May 2020.