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Atrial FibrillationeBRAVE-AFNCT04250220

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

A study testing e-Health based strategy: PPG-based screening using a smartphone and ECG patch in people with Atrial Fibrillation, run by LMU Klinikum at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
e-Health based strategy: PPG-based screening using a smartphone and ECG patch
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,400 participants
Where
1 siteGermany
Study dates
3 Feb 2020to Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • atrial fibrillation
  • oral anticoagulation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum der Universität München

    München, 81337

Other trials in Germany

About this study

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.

Being tested
e-Health based strategy: PPG-based screening using a smartphone and ECG patch
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-Health based strategy: PPG-based screening using a smartphone and ECG patchDiagnostic test

    PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch

Study groups in NCT04250220
Study groupRoleWhat they receive
intervention groupExperimentale-health-based strategy
Receives: Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch
control groupNo interventionsymptom based AF-screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation

    Measured: 6 months

Secondary outcomes (4)

  1. Number of participants with newly diagnosed atrial fibrillation

    Measured: 6 months

  2. Number of participants with newly prescribed oral anticoagulation

    Measured: 6 months

  3. Number of participants with stroke

    Measured: 6 months

  4. Number of participants with thromboembolic events

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start3 Feb 2020
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04250220
Sponsor's protocol ID
18-779
Acronym
eBRAVE-AF
Status last verified
Jun 2021
First submitted
24 Jan 2020
Last updated
18 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36031651

  • 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.

    PubMed 34252387

Questions about this trial

What is this clinical trial studying?

A study testing e-Health based strategy: PPG-based screening using a smartphone and ECG patch in people with Atrial Fibrillation, run by LMU Klinikum at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with newly diagnosed atrial fibrillation within six months with prescription of oral anticoagulation (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04250220, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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