Batch Enrollment for AI-Guided Intervention to Lower Neurologic Events in Unrecognized AF
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ClinicalTrials.gov Identifier: NCT04208971 |
Recruitment Status :
Enrolling by invitation
First Posted : December 23, 2019
Last Update Posted : November 12, 2020
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Condition or disease | Intervention/treatment |
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Atrial Fibrillation | Other: AI-enabled ECG-based Screening Tool for AF |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Batch Enrollment for an Artificial Intelligence-Guided Intervention to Lower Neurologic Events in Patients With Unrecognized Atrial Fibrillation (BEAGLE) |
Actual Study Start Date : | November 2, 2020 |
Estimated Primary Completion Date : | October 2021 |
Estimated Study Completion Date : | October 2022 |

Group/Cohort | Intervention/treatment |
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BEAGLE Participants
Adult patients who have not been previously diagnosed with AF, are eligible for anticoagulation and have AI-predicted risks based on a normal sinus rhythm ECG.
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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. |
- 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]).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208971
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Xiaoxi Yao, PhD, MPH | Mayo Clinic | |
Principal Investigator: | Peter Noseworthy, MD | Mayo Clinic |
Responsible Party: | Xiaoxi Yao, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT04208971 |
Other Study ID Numbers: |
19-012411 |
First Posted: | December 23, 2019 Key Record Dates |
Last Update Posted: | November 12, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |