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

NCT07205367 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-10-03

No results posted yet for this study

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

Interventions

DEVICE

Zio Monitor

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

Sponsors & Collaborators

  • iRhythm Technologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2025-07-29
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT07205367 on ClinicalTrials.gov