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

LMU Klinikum

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04250220

18-779

Details and patient eligibility

About

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.

Enrollment: 4,400 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• atrial fibrillation
• oral anticoagulation

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,400 participants in 2 patient groups

intervention group

Experimental group

Description:

e-health-based strategy

Treatment:

Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch

control group

No Intervention group

Description:

symptom based AF-screening