Atrial Fibrillation
Conditions
Brief summary
Atrial fibrillation (AF) is the most common arrhythmia in western countries and causes of up to one quarter of ischemic strokes. The randomized eHealth-based Bavarian Alternative Detection of Atrial Fibrillation study (eBRAVE-AF) tests the efficacy of an e-health based strategy for the detection of AF. The e-health-based strategy consists of a smartphone-based photophlethysmographic (PPG) screening and an ECG-based validation.
Interventions
DIAGNOSTIC_TESTe-Health based strategy: PPG-based screening using a smartphone and ECG patch
PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch
Sponsors
Preventicus GmbH
Versicherungskammer Bayern
LMU Klinikum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* policy holders of a large health insurance company * age ≥50 years * CHA2DS2-VASc ≥1 (females ≥2)
Exclusion criteria
* atrial fibrillation * oral anticoagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with newly diagnosed atrial fibrillation | 6 months |
| Number of participants with newly prescribed oral anticoagulation | 6 months |
| Number of participants with stroke | 6 months |
| Number of participants with thromboembolic events | 6 months |
Other
| Measure | Time frame |
|---|---|
| Number of participants with TIMI major bleeding | 6 months |
Countries
Germany
Outcome results
None listed