eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)

Not Applicable

• Conditions: Atrial Fibrillation

• Registration Number: NCT04250220
• Lead Sponsor: LMU Klinikum

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2020-02-03
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4400

Inclusion Criteria

• policy holders of a large health insurance company
• age ≥50 years
• CHA2DS2-VASc ≥1 (females ≥2)

Exclusion Criteria

• atrial fibrillation
• oral anticoagulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation	6 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with newly prescribed oral anticoagulation	6 months
Number of participants with thromboembolic events	6 months
Number of participants with newly diagnosed atrial fibrillation	6 months
Number of participants with stroke	6 months

Trial Locations

Locations (1)

Klinikum der Universität München; 🇩🇪 München, Germany