A Digital Non-interventional Atrial Fibrillation (AF) Screening Study With Commercial Pulse Detection Systems

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: 12-point-ECG
* Device: Polar V800
* Device: 360° eMotion FAROS SET + Belt
* Device: Adidas Micoach smart run
* Device: TomTom Runner Cardio HRM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial Fibrillation Patients<br>Adult female and male patients with diagnosed atrial fibrillation | Device: 12-point-ECG<br>* routine recording will be 300 seconds<br>Device: Polar V800<br>* routine recording will be 300 seconds<br>Device: 360° eMotion FAROS SET + Belt<br>* routine recording will be 300 seconds<br>Device: Adidas Micoach smart run<br>* routine recording will be 300 seconds<br>Device: TomTom Runner Cardio HRM<br>* routine recording will be 300 seconds<br>|
| Sinus Rhythm Patients<br>Adult female and male patients with diagnosed sinus rhythm | Device: 12-point-ECG<br>* routine recording will be 300 seconds<br>Device: Polar V800<br>* routine recording will be 300 seconds<br>Device: 360° eMotion FAROS SET + Belt<br>* routine recording will be 300 seconds<br>Device: Adidas Micoach smart run<br>* routine recording will be 300 seconds<br>Device: TomTom Runner Cardio HRM<br>* routine recording will be 300 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinus rhythm