eHealth-based Bavarian Alternative Detection of Atrial Fibrillation: A Randomized Controlled Trial (eBRAVE-AF)
NCT ID: NCT04250220
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4400 participants
INTERVENTIONAL
2020-02-03
2021-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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intervention group
e-health-based strategy
e-Health based strategy: PPG-based screening using a smartphone and ECG patch
PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch
control group
symptom based AF-screening
No interventions assigned to this group
Interventions
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e-Health based strategy: PPG-based screening using a smartphone and ECG patch
PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch
Eligibility Criteria
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Inclusion Criteria
* age ≥50 years
* CHA2DS2-VASc ≥1 (females ≥2)
Exclusion Criteria
* oral anticoagulation
50 Years
ALL
No
Sponsors
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Preventicus GmbH
INDUSTRY
Versicherungskammer Bayern
UNKNOWN
LMU Klinikum
OTHER
Responsible Party
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Axel Bauer
Prof. Dr.
Principal Investigators
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Axel Bauer, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Klinikum
Locations
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Klinikum der Universität München
München, , Germany
Countries
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References
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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.
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.
Other Identifiers
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18-779
Identifier Type: -
Identifier Source: org_study_id
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