NCT05923359
Active, Not Recruiting
N/A
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
ConditionsAtrial Fibrillation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Mayo Clinic
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Atrial fibrillation
- Status
- Active, Not Recruiting
- Last Updated
- 3 months ago
Overview
Brief 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.
Investigators
Xiaoxi Yao
Principal Investigator
Mayo Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Atrial fibrillation
Time Frame: 2 years
Number of participants diagnosed with atrial fibrillation
Secondary Outcomes
- Ischemic stroke or systemic embolism events(2 years)
- Major bleeding(2 years)
- Change in individuals' maximum learning span(Baseline, 2 years)
- Change in processing speed measure(Baseline, 2 years)
- Mortality(2 years)
Study Sites (1)
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