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

Atrial Fibrillation Clinical Trial

— eBRAVE-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04250220
• Other study ID #: 18-779
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: July 2021

Study information

• Verified date: June 2021
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4400
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• policy holders of a large health insurance company

• age =50 years

• CHA2DS2-VASc =1 (females =2)

Exclusion Criteria:

• atrial fibrillation

• oral anticoagulation

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• e-Health based strategy: PPG-based screening using a smartphone and ECG patch
PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch

Locations

Country	Name	City	State
Germany	Klinikum der Universität München	München

Sponsors (3)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen	Preventicus GmbH, Versicherungskammer Bayern

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with TIMI major bleeding		6 months
Primary	Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation		6 months
Secondary	Number of participants with newly diagnosed atrial fibrillation		6 months
Secondary	Number of participants with newly prescribed oral anticoagulation		6 months
Secondary	Number of participants with stroke		6 months
Secondary	Number of participants with thromboembolic events		6 months