Back to resultseHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF) (eBRAVE-AF)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
e-Health based strategy: PPG-based screening using a smartphone and ECG patch
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Klinikum der Universität München
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
e-health-based strategy
symptom based AF-screening
Outcomes
Primary Outcome Measures
Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation
Secondary Outcome Measures
Number of participants with newly diagnosed atrial fibrillation
Number of participants with newly prescribed oral anticoagulation
Number of participants with stroke
Number of participants with thromboembolic events
Full Information
NCT ID
NCT04250220
First Posted
January 24, 2020
Last Updated
June 17, 2021
Sponsor
LMU Klinikum
Collaborators
Preventicus GmbH, Versicherungskammer Bayern
1. Study Identification
Unique Protocol Identification Number
NCT04250220
Brief Title
eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
Acronym
eBRAVE-AF
Official Title
eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum
Collaborators
Preventicus GmbH, Versicherungskammer Bayern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
e-health-based strategy
Arm Title
control group
Arm Type
No Intervention
Arm Description
symptom based AF-screening
Intervention Type
Diagnostic Test
Intervention Name(s)
e-Health based strategy: PPG-based screening using a smartphone and ECG patch
Intervention Description
PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch
Primary Outcome Measure Information:
Title
Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with newly diagnosed atrial fibrillation
Time Frame
6 months
Title
Number of participants with newly prescribed oral anticoagulation
Time Frame
6 months
Title
Number of participants with stroke
Time Frame
6 months
Title
Number of participants with thromboembolic events
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Number of participants with TIMI major bleeding
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Bauer, MD
Organizational Affiliation
LMU Klinikum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum der Universität München
City
München
ZIP/Postal Code
81337
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36031651
Citation
Rizas KD, Freyer L, Sappler N, von Stulpnagel L, Spielbichler P, Krasniqi A, Schreinlechner M, Wenner FN, Theurl F, Behroz A, Eiffener E, Klemm MP, Schneidewind A, Zens M, Dolejsi T, Mansmann U, Massberg S, Bauer A. Smartphone-based screening for atrial fibrillation: a pragmatic randomized clinical trial. Nat Med. 2022 Sep;28(9):1823-1830. doi: 10.1038/s41591-022-01979-w. Epub 2022 Aug 28.
Results Reference
derived
PubMed Identifier
34252387
Citation
Freyer L, von Stulpnagel L, Spielbichler P, Sappler N, Wenner F, Schreinlechner M, Krasniqi A, Behroz A, Eiffener E, Zens M, Dolejsi T, Massberg S, Rizas KD, Bauer A. Rationale and design of a digital trial using smartphones to detect subclinical atrial fibrillation in a population at risk: The eHealth-based bavarian alternative detection of Atrial Fibrillation (eBRAVE-AF) trial. Am Heart J. 2021 Nov;241:26-34. doi: 10.1016/j.ahj.2021.06.008. Epub 2021 Jul 9.
Results Reference
derived
Learn more about this trial
eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
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