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Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF

Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04208971
Enrollment
1225
Registered
2019-12-23
Start date
2020-11-02
Completion date
2022-01-27
Last updated
2022-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

This is a prospective study to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis of unrecognized atrial fibrillation (AF) and stroke prevention.

Interventions

OTHERAI-enabled ECG-based Screening Tool for AF

A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool to improve atrial fibrillation diagnosis and stroke prevention.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Had a 10-second 12-lead ECG done at Mayo Clinic * Men with CHA2DS2-VASc ≥2 or women with CHA2DS2-VASc ≥3

Exclusion criteria

* Diagnosed atrial fibrillation or atrial flutter * Missing date of birth or sex in the electronic health record (EHR) * A history of intracranial bleeding * A history of end-stage kidney disease * Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder * Deemed by research personnel to have limitations that would prevent them from being able to provide informed consent, use the patch, or complete interviews will not be included.

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of Atrial Fibrillation as Detected by Patch ApplicationThree MonthsThe data will be used to examine the performance of the algorithm in detecting unrecognized atrial fibrillation (e.g. positive predictive value, negative predictive value, sensitivity, specificity, and area under the curve \[AUC\]).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026