NCT02875106CompletedNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
The rate of correctly detected atrial fibrillation signals by CPDS in reference to ECG (sensitivity of CPDS).
Time Frame: 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 Outcomes
- 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)
- 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)
- The rate of correctly detected sinus rhythm signals by CPDS in reference to ECG (sensitivity of CPDS).(120 seconds)
Investigators
Study Sites (1)
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