Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT07205367
Eligibility Criteria:
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07205367
Study Brief:
Protocol Section:
NCT07205367