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.
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. Seventy-five (75) participants in Phase I and 75 participants in Phase II 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
150
The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
iRhythm Technologies - San Francisco, CA
San Francisco, California, United States
iRhythm Technologies - Deerfield, IL
Deerfield, Illinois, United States
Mean Wear Duration
This outcome measure is met if the mean wear duration is greater than 21 days
Time frame: 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.
Time frame: 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.
Time frame: Up to 30 days (Day 30)
Additional Device Measure 1: Signal Artifact
Percent signal artifact is defined as the proportion of ECG signal that is artifact over the wear duration, reported for each study device. Signal artifact is a continuous value representing the percentage of the wear duration that was not interpretable. This variable will be calculated as the inverse of analyzable ECG percent. Signal artifact will be summarized using the population meeting protocol requirements and include means and 95% confidence intervals for these proportions.
Time frame: Up to 30 days (Day 30)
Additional Device Measure 2: Device Functionality
Device functionality is defined as the number of participants with Zio monitors recording a continuous ECG signal through 21 and 30 days. The ability to record a continuous ECG signal is defined as device functionality. Device functionality will be determined by the number of participants with devices adhering to the skin, the number of participants with devices functioning/operating and the number of participants with devices that are recording and ECG signal.
Time frame: At 21 days (Day 21) and 30 days (Day 30)
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Observational Assessment: Skin Dryness Level
This includes an assessment of the following skin types: dry, oily and normal.
Time frame: Baseline (Day 1)
Observational Assessment: Hyperhydrosis Status
This includes an assessment of the following hyperhydrosis status: primary, secondary or none.
Time frame: Baseline (Day 1)
Observational Assessment: Fitzpatrick Skin Type
This includes a 6-point scale to assess the following skin types: (1) pale skin; always burns, never tans; (2) fair skin; usually burns, tans minimally; (3) darker white skin; sometimes mild burn, tans uniformly; (4) light brown skin; burns minimally, always tans well; (5) brown skin; very rarely burns; tans very easily; (6) dark brown or black skin; never burns.
Time frame: Baseline (Day 1)
Observational Assessment: Chest Hair Density
This includes an assessment of the following chest hair density types: smooth/no hair; some hair; moderately hairy; or very hairy in the target patch placement area.
Time frame: Baseline (Day 1)