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

June 17, 2021 updated by: Axel Bauer, LMU Klinikum
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, 81337
        • Klinikum der Universität München

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
e-health-based strategy
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
No Intervention: control group
symptom based AF-screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with newly diagnosed atrial fibrillation
Time Frame: 6 months
6 months
Number of participants with newly prescribed oral anticoagulation
Time Frame: 6 months
6 months
Number of participants with stroke
Time Frame: 6 months
6 months
Number of participants with thromboembolic events
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Number of participants with TIMI major bleeding
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMU Klinikum

Collaborators

Preventicus GmbH
Versicherungskammer Bayern

Investigators

  • Principal Investigator: Axel Bauer, MD, LMU Klinikum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 31, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-779

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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