Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II

Completed · Not applicable

Conditions studied: Cardiac Arrhythmia

In brief

This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the percentage of analyzable electrocardiographic time and (3) safety by reviewing all adverse events.

Key facts

Study ID: NCT07205367
Run by: iRhythm Technologies, Inc.
People needed: 150
Starts: 2025-01-06
Expected to finish: 2025-11-07
Last updated by the study team: 2026-08-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Participant must be 18 years or older at time of informed consent.
Participant is willing and able to provide informed consent and be able to complete all visits for the study.

You may not qualify if…

Participant has a known allergy to adhesives.
Participant has a current skin infection or injury at location for study device placement.
Participant is a member of a vulnerable population.
Participant is a current or prior employee of iRhythm.
Participant is unable or unwilling to participate or comply with study protocol.
The local Investigator deems the participant has a condition that could limit the participant's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits.
Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant.
Participant has an external cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
Participant does not have the competency to wear the device for the prescribed monitoring period.
Participant does not have the ability to consent for themselves (i.e., no LARs).

Where it is running

iRhythm Technologies - San Francisco, CA — San Francisco, California, United States
iRhythm Technologies - Deerfield, IL — Deerfield, Illinois, United States

Full record on ClinicalTrials.gov

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