Clinical Trial

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

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Trial completed 2026-08-06
minor Trial arms changed: 1 -> 2 2026-08-06
Trial Details
NCT Number NCT07205367
Lead Sponsor iRhythm Technologies, Inc.
Conditions Cardiac Arrhythmia
Enrollment 150 participants
Start Date 2025-01-06
Primary Completion 2025-07-29 (estimated)
Study Completion 2025-11-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-05