Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

Atrial Fibrillation Clinical Trial

Official title:

Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05923359
• Other study ID #: 22-011253
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Had a 10-second 12-lead ECG done at Mayo Clinic

• Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF

• Men with CHA2DS2-VASc2 =2 or women with CHA2DS2-VASc = 3

Exclusion Criteria:

• Diagnosed atrial fibrillation

• Diagnosed dementia

• Diagnosed end-stage kidney disease

• History of intracranial bleeding

• Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder

• Missing date of birth

• Residence outside of the U.S. or missing address information

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Apple Watch
Apple Watch

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	Atrial fibrillation	Number of participants diagnosed with atrial fibrillation	2 years
Secondary	Change in individuals' maximum learning span	Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance. Maximum learning span is total number of words recognized.	Baseline, 2 years
Secondary	Change in processing speed measure	Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses a symbols test to measure processing speed reported in average completion time (seconds).	Baseline, 2 years
Secondary	Ischemic stroke or systemic embolism events	Number of ischemic stroke or systemic embolism events	2 years
Secondary	Major bleeding	Number of major bleeding events	2 years
Secondary	Mortality	Number of participant deaths	2 years