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OpenTrials
Completed

NCT Number: NCT04208971

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-enabled ECG-based Screening Tool for AF

Other

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

Primary outcomes

  1. Diagnosis of Atrial Fibrillation as Detected by Patch Application

    Time frame: Three Months

    The 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]).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2019
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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