BAYathlon: A Digital Non-interventional Atrial Fibrillation (AF) Screening Study With Commercial Pulse Detection Systems
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Atrial Fibrillation Patients Adult female and male patients with diagnosed atrial fibrillation |
Device: 12-point-ECG
routine recording will be 300 seconds
Device: Polar V800
routine recording will be 300 seconds
Device: 360° eMotion FAROS SET + Belt
routine recording will be 300 seconds
Device: Adidas Micoach smart run
routine recording will be 300 seconds
Device: TomTom Runner Cardio HRM
routine recording will be 300 seconds
|
| Sinus Rhythm Patients Adult female and male patients with diagnosed sinus rhythm |
Device: 12-point-ECG
routine recording will be 300 seconds
Device: Polar V800
routine recording will be 300 seconds
Device: 360° eMotion FAROS SET + Belt
routine recording will be 300 seconds
Device: Adidas Micoach smart run
routine recording will be 300 seconds
Device: TomTom Runner Cardio HRM
routine recording will be 300 seconds
|
Outcome Measures
Primary Outcome Measures
- The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS). [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).
Secondary Outcome Measures
- The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS). [120 seconds]
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).
- 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). [120 seconds]
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.
- The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS). [60 seconds, 180 seconds, 240 seconds, 300 seconds]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | Germany |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 18796