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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation Patients | Adult female and male patients with diagnosed atrial fibrillation |
| |
| Sinus Rhythm Patients | Adult female and male patients with diagnosed sinus rhythm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-point-ECG | Device | routine recording will be 300 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 120 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 120 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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Patients for whom the decision to record an ECG was made as per investigator's routine treatment practice
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34104466 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Polar V800 | Device | routine recording will be 300 seconds |
|
| 360° eMotion FAROS SET + Belt | Device | routine recording will be 300 seconds |
|
| Adidas Micoach smart run | Device | routine recording will be 300 seconds |
|
| TomTom Runner Cardio HRM | Device | routine recording will be 300 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. | 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). | 60 seconds, 180 seconds, 240 seconds, 300 seconds |
| D013568 |
| Pathological Conditions, Signs and Symptoms |