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Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
Sponsor: iRhythm Technologies, Inc.
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-01-06
Completion Date
2025-10-31
Last Updated
2025-10-03
Healthy Volunteers
Yes
Conditions
Interventions
Zio Monitor
The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
Locations (2)
iRhythm Technologies - San Francisco, CA
San Francisco, California, United States
iRhythm Technologies - Deerfield, IL
Deerfield, Illinois, United States