Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults aged 40 or older who have had an ECG during routine care. For the atrial fibrillation group, participants must be 65 or older and able to identify a healthcare provider to receive patch monitor results. For structural heart disease, they need to be at least 40 and can't have severe valve issues or poor heart pump function.Treatment Details
The study tests two devices: an echocardiogram and Zio Patch Monitor, which may help predict atrial fibrillation or structural heart disease using electrocardiogram results. It includes looking back at past patient data as well as monitoring new patients.
2Treatment groups
Experimental Treatment
Group I: SHD CohortExperimental Treatment1 Intervention
Will be comprised 500 participants at increased risk for Structural Heart Disease (SHD) will be referred for a single echocardiogram.
Group II: AF CohortExperimental Treatment1 Intervention
Will be comprised of 500 participants predicted to be increased risk for Atrial Fibrillation (AF) will receive a 2-week ECG patch monitor to wear (up to 3 times over 12 months),
Find a clinic near you
Research locations nearbySelect from list below to view details:
Geisinger Medical CenterDanville, PA
Corewell HealthGrand Rapids, MI
TriHealthCincinnati, OH
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Who is running the clinical trial?
Tempus AILead Sponsor
Tempus LabsLead Sponsor