Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II (NCT07205367) | Clinical Trial Compass
CompletedNot Applicable
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
United States150 participantsStarted 2025-01-06
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was studying how well people could actually wear the Zio Monitor for an extended period — since the study is now completed, has the data been published, and what did it show about how long patients were typically able to keep the device on?
2The study specifically measured skin irritation as a safety outcome — is skin sensitivity or irritation something I should be concerned about if I were to use an extended-wear cardiac monitor like this, and are there factors about my own skin health that might matter?
3Since this was a device validation study rather than a treatment trial, how does the evidence it generated compare to what my doctor already knows about using the Zio Monitor to detect my type of arrhythmia?
4The study tracked what percentage of wear time produced usable heart rhythm data — based on results like this, how confident can my care team be that a long-term wearable monitor would actually capture the arrhythmia episodes I'm experiencing?
5Given that this study has already been completed, would my doctor consider the Zio Monitor a well-supported option for monitoring my cardiac arrhythmia right now, or are there other monitoring approaches worth comparing it to?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.