Atrial fibrillation is an abnormal beating of the heart that can lead to stroke or heart failure. Structural heart diseases are conditions that affect the heart valves or heart muscle and can cause permanent heart damage if left untreated. Sometimes people have atrial fibrillation or structural heart disease and do not know it. The purpose of this study is to evaluate two devices that can predict who has or may develop atrial fibrillation or structural heart disease based on the results of an electrocardiogram.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
Patch monitor will be applied and worn for a 2-week period at baseline, month 6, and month 12 after assignment to the AF arm.
Ultrasound study of the heart will be completed upon patient consent after assignment to the SHD arm.
Corewell Health
Grand Rapids, Michigan, United States
TriHealth
Cincinnati, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Positive-predictive value (PPV) of the AF device at six months
AF will be defined by findings from the patch monitor, participant interview or the EHR-based phenotype definition and will be considered positive if a diagnosis occurs within 6 months of the index ECG.
Time frame: 12 months
Positive-predictive value (PPV) of the SHD device at six months
Structural heart disease will be defined as: * moderate or severe mitral stenosis, aortic regurgitation, or aortic stenosis * severe mitral or tricuspid regurgitation * LVEF ≤ 40% * Interventricular septal thickness \>15mm
Time frame: 12 months
Positive-predictive value (PPV) of the AF device at 12 months
AF will be defined by findings from the patch monitor, participant interview or the EHR-based phenotype definition and will be considered positive if a diagnosis occurs within 12 months of the index ECG.
Time frame: 18 months
Positive-predictive value (PPV) of the SHD device at 12 months
Structural heart disease will be defined as: * moderate or severe mitral stenosis, aortic regurgitation, or aortic stenosis * severe mitral or tricuspid regurgitation * LVEF ≤ 40% * Interventricular septal thickness \>15mm
Time frame: 18 months
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