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

NCT07205367 | Active Not Recruiting DMC FDA Device

• 1 other identifier: iRT-003-2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (3)

• Mean Wear Duration

  This outcome measure is met if the mean wear duration is greater than 21 days

  21 - 30 days after baseline

• Percent Analyzable Time

  This outcome measure is met if the percent analyzable time is greater than 80% in 90% of subjects.

  Up to 30 days (Day 30)

• Safety: Skin Irritation

  This includes the proportion of participants that experience clinically significant skin irritation through 30 days of wear. This will be assessed through the capture and reporting of all adverse events

  Up to 30 days (Day 30)

Secondary Outcomes (6)

• Additional Device Measure 1: Percent Signal Artifact

  Up to 30 days (Day 30)

• Additional Device Measure 2: Percent Device Functionality

  At 21 days (Day 21) and 30 days (Day 30)

• Observational Assessment: Skin Dryness Level

  Baseline (Day 1)

• Observational Assessment: Hyperhydrosis Status

  Baseline (Day 1)

• Observational Assessment: Fitzpatrick Skin Type

  Baseline (Day 1)

Study Arms (1)

Open Label

OTHER

This is an open-label study. All participants will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.

Device: Zio Monitor

Interventions

Zio Monitor DEVICE

The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.

Open Label

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• iRhythm Technologies, Inc.: lead

Study Sites (2)

iRhythm Technologies - San Francisco, CA

San Francisco, California, 94103, United States

Location

iRhythm Technologies - Deerfield, IL

Deerfield, Illinois, 60015, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a design validation study to evaluate the wear performance of the Zio monitor/Zio MCT device form factor.

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 3, 2025
• Study Start: January 6, 2025
• Primary Completion: July 29, 2025
• Study Completion: October 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)