Trial Condition(s):
Atrial Fibrillation
A digital non-interventional atrial fibrillation (AF) screening study with commercial pulse detection systems (BAYathlon)
Bayer Identifier:
18796
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Device
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- 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).Timeframe: 120 seconds
Secondary Outcome
- 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).Timeframe: 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.Timeframe: 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).Timeframe: 60 seconds, 180 seconds, 240 seconds, 300 seconds
Additional Information
Copyright © Bayer
Powered by
