CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 1,000 target
Drug / intervention
Zio Patch Monitor +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05442203
NCT05442203N/AActiveUpdate OverdueUpdated 23mo ago · Completion was 12mo ago
Enrollment Stalled
CompareCT.gov

Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease

Tempus AI·interventional·Posted Jul 1, 2022·Updated Jul 25, 2024

In Brief

A clinical study evaluating Zio Patch Monitor and Echocardiogram for Atrial Fibrillation and Structural Heart Disease. Active but no longer recruiting, targeting 1,000 participants across 3 sites.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Structural Heart Disease
CountriesUnited States
Collaborators--

Timeline

N/AActiveOverdue
2023202420252026
First PostedJul 1, 2022
Enrollment StartSep 7, 2022
Primary CompletionJul 1, 2025
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.0 years ago

Interventions

Zio Patch Monitordevice

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.

Echocardiogramdevice

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