NCT04250220

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,400

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 3, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

January 24, 2020

Last Update Submit

June 17, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (4)

  • Number of participants with newly diagnosed atrial fibrillation

    6 months

  • Number of participants with newly prescribed oral anticoagulation

    6 months

  • Number of participants with stroke

    6 months

  • Number of participants with thromboembolic events

    6 months

Other Outcomes (1)

  • Number of participants with TIMI major bleeding

    6 months

Study Arms (2)

intervention group

EXPERIMENTAL

e-health-based strategy

Diagnostic Test: e-Health based strategy: PPG-based screening using a smartphone and ECG patch

control group

NO INTERVENTION

symptom based AF-screening

Interventions

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

intervention group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • atrial fibrillation
  • oral anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Universität München

München, 81337, Germany

Location

Related Publications (2)

  • 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.

    PMID: 36031651DERIVED

  • 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.

    PMID: 34252387DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Axel Bauer, MD

    LMU Klinikum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 31, 2020

Study Start

February 3, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)