Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250220
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : February 20, 2020
Sponsor:
Collaborators:
Preventicus GmbH
Versicherungskammer Bayern
Information provided by (Responsible Party):
Axel Bauer, Klinikum der Universitaet Muenchen

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Number of participants with newly diagnosed atrial fibrillation [ Time Frame: 6 months ]
  2. Number of participants with newly prescribed oral anticoagulation [ Time Frame: 6 months ]
  3. Number of participants with stroke [ Time Frame: 6 months ]
  4. Number of participants with thromboembolic events [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Number of participants with TIMI major bleeding [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • atrial fibrillation
  • oral anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250220


Contacts
Layout table for location contacts
Contact: Axel Bauer, MD +49 89 4400 ext 73172 axel.bauer@med.uni-muenchen.de
Contact: Luisa Freyer, MD +49 89 4400 ext 73172 luisa.freyer@med.uni-muenchen.de

Locations
Layout table for location information
Germany
Klinikum der Universität München Recruiting
München, Germany, 81337
Contact: Axel Bauer, MD    +49 89 4400 ext 73172    axel.bauer@med.uni-uenchen.de   
Contact: Luisa Freyer, MD    +49 89 4400 ext 73172    luisa.freyer@med.uni-muenchen.de   
Principal Investigator: Axel Bauer, MD         
Principal Investigator: Konstantinos Rizas, MD         
Sub-Investigator: Luisa Freyer, MD         
Sponsors and Collaborators
Klinikum der Universitaet Muenchen
Preventicus GmbH
Versicherungskammer Bayern
Investigators
Layout table for investigator information
Principal Investigator: Axel Bauer, MD Klinikum der Universitaet Muenchen
Layout table for additonal information
Responsible Party: Axel Bauer, Prof. Dr., Klinikum der Universitaet Muenchen
ClinicalTrials.gov Identifier: NCT04250220    
Other Study ID Numbers: 18-779
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes