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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208971
• Other study ID #: 19-012411
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: January 27, 2022

Study information

• Verified date: August 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• AI-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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Atrial Fibrillation as Detected by Patch Application	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]).	Three Months

External Links

•   Mayo Clinic Clinical Trials