NCT05442203

Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Tempus AI · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Structural Heart Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-07
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-07-01
• Last updated: 2024-07-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study