Atrial Fibrillation
Conditions
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.
Interventions
OTHERApple Watch
Apple Watch
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation | 2 years | Number of participants diagnosed with atrial fibrillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in individuals' maximum learning span | Baseline, 2 years | 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. |
| Change in processing speed measure | Baseline, 2 years | 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). |
| Ischemic stroke or systemic embolism events | 2 years | Number of ischemic stroke or systemic embolism events |
| Major bleeding | 2 years | Number of major bleeding events |
| Mortality | 2 years | Number of participant deaths |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORXiaoxi Yao, PhD
Mayo Clinic
Outcome results
None listed