Atrial Fibrillation
Conditions
Keywords
Sinus rhythm
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.
Interventions
DEVICE12-point-ECG
routine recording will be 300 seconds
DEVICEPolar V800
routine recording will be 300 seconds
DEVICE360° eMotion FAROS SET + Belt
routine recording will be 300 seconds
DEVICEAdidas Micoach smart run
routine recording will be 300 seconds
DEVICETomTom Runner Cardio HRM
routine recording will be 300 seconds
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Germany
Outcome results
None listed