Status:
ACTIVE_NOT_RECRUITING
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
Lead Sponsor:
iRhythm Technologies, Inc.
Conditions:
Cardiac Arrhythmia
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
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 t...
Eligibility Criteria
Inclusion
- Participant must be 18 years or older at time of informed consent.
- Participant is willing and able to provide informed consent and be able to complete all visits for the study.
Exclusion
- Participant has a known allergy to adhesives.
- Participant has a current skin infection or injury at location for study device placement.
- Participant is a member of a vulnerable population.
- Participant is a current or prior employee of iRhythm.
- Participant is unable or unwilling to participate or comply with study protocol.
- 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.
- Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant.
- 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.
- Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
- Participant does not have the competency to wear the device for the prescribed monitoring period.
- Participant does not have the ability to consent for themselves (i.e., no LARs).
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07205367
Start Date
January 6 2025
End Date
October 31 2025
Last Update
October 3 2025
Active Locations (2)
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1
iRhythm Technologies - San Francisco, CA
San Francisco, California, United States, 94103
2
iRhythm Technologies - Deerfield, IL
Deerfield, Illinois, United States, 60015