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Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

NCT05442203 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-07-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • John Pfeifer, MD · Tempus AI, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05442203 on ClinicalTrials.gov