NCT07205367

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: iRhythm Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a prospective, multi-center, single-arm study to validate the design of the Zio monitor/Zio MCT device form factor in extended (21-day) wear when utilizing an updated skin prep process. The trial is conducted in 2 phases. Phase I includes the standard skin preparation process of 40 strokes with an exfoliator in 4 different directions. Phase II incorporates a modified skin preparation process: only 20 strokes with an exfoliator in 2 directions are used. There are 75 participants in each phase. Performance objectives include the following: (1) Mean wear duration of 21 days and (2) percent analyzable time of 80%. Safety measures include the proportion of participants that experience clinically significant skin irritation through 30 days of wear, as well as the reporting of all adverse events. Additional device measures include the following: (1) % signal artifact (defined as the proportion of ECG signal that is artifact over the wear duration, reported for each study device); (2) % device functionality (defined as the proportion of Zio monitors recording a continuous ECG signal through 21 days, and through 30 days) and (3) observational assessment of participant skin types (assessed by dryness levels, hyperhydrosis status, Fitzpatrick Skin Type and chest hair density). All analyses will be performed on the population of enrolled participants on whom the Zio monitor application was attempted. The age, sex at birth, and application type (i.e., healthcare provider (HCP) designee vs. self-application) of participants will be monitored throughout the enrollment period to ensure representation across key user groups. Performance within subgroups including (but not limited to) sex at birth, age, and application type will be assessed. Up to 150 participants will be enrolled at 2 US iRhythm locations (San Francisco, CA and Deerfield, IL). There are 3 on-location visits at Baseline (Visit 1/time of patch application), Day 21 (Visit 4) and Day 30 (Visit 5/following 30 days of patch application). There are 2 telephone/video calls at Day 7 (Visit 2) and Day 14 (Visit 3). Participants who meet all inclusion criteria and no exclusion criteria will be enrolled.

Conditions

• Cardiac Arrhythmia

Interventions

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

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-07-29
• Completion: 2025-10-31
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study