CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,135 enrolled
Drug / intervention
iRhythm ZIO XT Patch +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/NCT02506244
NCT02506244N/ACompleted
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mHealth Screening to Prevent Strokes (mSToPS)

Scripps Translational Science Institute·interventional·Posted Jul 23, 2015·Updated Dec 8, 2022

In Brief

A clinical study evaluating iRhythm ZIO XT Patch and Wristband by Amiigo for Atrial Fibrillation. Completed, enrolled 6,135 participants across 1 site.

Detailed Summary

The purpose of this study is to investigate whether it is possible to identify a high-risk cohort suitable for screening for asymptomatic atrial fibrillation using claims data, and then engage those individuals in a mobile health technology-enabled home monitoring program in order to document previously undiagnosed atrial fibrillation, and provide clinical evidence of an outcomes benefit associated with this early detection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
CollaboratorsJanssen Scientific Affairs, LLC, Aetna, Inc.

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartNov 1, 2015
Primary CompletionSep 1, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.9 years ago

Interventions

iRhythm ZIO XT Patchdevice

Single-lead ECG monitoring via a wearable patch

Wristband by Amiigodevice

Determines pulse rate using photoplethysmography.