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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple Watch Intervention Group | Experimental | Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team. |
|
| Control Group | No Intervention | Participants will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Watch | Other | Apple Watch |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation | Number of participants diagnosed with atrial fibrillation | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoxi Yao, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37913853 | Derived | Yao X, Attia ZI, Behnken EM, Hart MS, Inselman SA, Weber KC, Li F, Stricker NH, Stricker JL, Friedman PA, Noseworthy PA. Realtime Diagnosis from Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation with Long Follow-Up (REGAL): Rationale and design of a pragmatic, decentralized, randomized controlled trial. Am Heart J. 2024 Jan;267:62-69. doi: 10.1016/j.ahj.2023.10.005. Epub 2023 Oct 30. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Baseline, 2 years |
| 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 |
| Ischemic stroke or systemic embolism events | Number of ischemic stroke or systemic embolism events | 2 years |
| Major bleeding | Number of major bleeding events | 2 years |
| Mortality | Number of participant deaths | 2 years |
| D013568 |
| Pathological Conditions, Signs and Symptoms |