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ACTIVE NOT RECRUITING
NCT05442203
NA

Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Sponsor: Tempus AI

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2022-09-07

Completion Date

2025-07

Last Updated

2024-07-25

Healthy Volunteers

No

Interventions

DEVICE

Zio Patch Monitor

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.

DEVICE

Echocardiogram

Ultrasound study of the heart will be completed upon patient consent after assignment to the SHD arm.

Locations (3)

Corewell Health

Grand Rapids, Michigan, United States

TriHealth

Cincinnati, Ohio, United States

Geisinger Medical Center

Danville, Pennsylvania, United States