AI-Assisted Heart Monitoring for Heart Disease
(ECG-AID Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJohn Pfeifer, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tempus AI

No Placebo Group

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.

Inclusion Criteria

I am over 40 and had an ECG for care between the study dates. I can name a healthcare provider for my echocardiogram results.

I am 65 or older and can name a healthcare provider to get my heart monitor results.

I am 40 or older and have had an ECG as part of my regular health care.

Exclusion Criteria

You cannot finish the follow-up studies on time, are currently in the hospital, have a permanent pacemaker or implanted cardiac defibrillator, have a history of certain heart conditions, had recent or planned heart surgery, or are allergic to adhesive.

I can follow the study schedule and am not currently hospitalized. I don't have severe heart valve issues, weak heart muscle, thick heart walls, or an allergy to ultrasound gel.

Retrospective Phase: Patients who have previously requested that their data not be involved in any secondary use application such as a research study

Participant Groups

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),