Cardiac Arrhythmia
Conditions
Brief 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. 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.
Interventions
DEVICEZio Monitor
The Zio monitor is a long-term continuous ambulatory patch ECG monitor which adheres to the patient's left pectoral region.
Sponsors
iRhythm Technologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a design validation study to evaluate the wear performance of the Zio monitor/Zio MCT device form factor.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Participant must be 18 years or older at time of informed consent. 2. Participant is willing and able to provide informed consent and be able to complete all visits for the study.
Exclusion criteria
1. Participant has a known allergy to adhesives. 2. Participant has a current skin infection or injury at location for study device placement. 3. Participant is a member of a vulnerable population. 4. Participant is a current or prior employee of iRhythm. 5. Participant is unable or unwilling to participate or comply with study protocol. 6. The local Investigator deems the participant has a condition that could limit the participant's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits. 7. Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant. 8. Participant has an external cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period. 9. Participant has a neuro-stimulator, as it may disrupt the quality of ECG data. 10. Participant does not have the competency to wear the device for the prescribed monitoring period. 11. Participant does not have the ability to consent for themselves (i.e., no LARs).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Wear Duration | 21 - 30 days after baseline | This outcome measure is met if the mean wear duration is greater than 21 days |
| Percent Analyzable Time | Up to 30 days (Day 30) | This outcome measure is met if the percent analyzable time is greater than 80% in 90% of subjects. |
| Safety: Skin Irritation | Up to 30 days (Day 30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional Device Measure 1: Signal Artifact | Up to 30 days (Day 30) | 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. |
| Additional Device Measure 2: Device Functionality | At 21 days (Day 21) and 30 days (Day 30) | 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. |
| Observational Assessment: Skin Dryness Level | Baseline (Day 1) | This includes an assessment of the following skin types: dry, oily and normal. |
| Observational Assessment: Hyperhydrosis Status | Baseline (Day 1) | This includes an assessment of the following hyperhydrosis status: primary, secondary or none. |
| Observational Assessment: Fitzpatrick Skin Type | Baseline (Day 1) | 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. |
| Observational Assessment: Chest Hair Density | Baseline (Day 1) | 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. |
Countries
United States
Participant flow
Recruitment details
This trial had 2 phases; 75 participants were in each phase. An external vendor conducted recruitment 02Dec24 - 31Jan25 for Phase I & 07May25 - 06Jun25 for Phase II. The same recruitment methods (IRB-approved email solicitation & social media posting) were used for each phase. A study population representative of the intended Zio monitor use & those who met eligibility criteria were approached. Enrolled participants were seen at 1 of 2 Sponsor locations (San Francisco, CA or Deerfield, IL).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 18 - 50 years | 30 Participants |
| Age, Customized Age 51 - 70 years | 72 Participants |
| Age, Customized Age > 70 years | 44 Participants |
| Ethnicity (NIH/OMB) Ethnicity Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Ethnicity Not Hispanic or Latino | 130 Participants |
| Ethnicity (NIH/OMB) Ethnicity Unknown or Not Reported | 0 Participants |
| Patch Application Method Health Care Provider or Designee | 50 Participants |
| Patch Application Method Self Application | 52 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Race Asian | 20 Participants |
| Race (NIH/OMB) Race Black or African American | 9 Participants |
| Race (NIH/OMB) Race More than one race | 3 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Race White | 51 Participants |
| Region of Enrollment United States | 146 participants |
| Sex: Female, Male Sex Female | 34 Participants |
| Sex: Female, Male Sex Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 45 / 75 | 52 / 75 |
| serious Total, serious adverse events | 0 / 75 | 0 / 75 |
Outcome results
None listed