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:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT04512703
Eligibility Criteria:
-Inclusion Criteria
The following criteria will be used to include subjects in phase I portion of the study:
* Healthy male and female volunteers.
* Subjects older than 21 years of age.
* Subjects willing to wear the µCor device for up to 30 days.
* Subjects willing to answer weekly phone calls from the study staff.
The following criteria will be used to include subjects in phase II portion of the study:
* Patients with a clinical indication for outpatient cardiac monitoring.
* Patients older than 21 years of age.
* Patients willing to wear the µCor device for up to 90 days.
* Patients willing to make monthly (30-, 60-, and 90-day) office visits during the study period.
* Patients willing to answer weekly phone calls regarding their health status.
* Exclusion Criteria:
The following criteria will be used to exclude subjects from phases I and II portions of the study:
* Subjects reporting or planning to be pregnant.
* Subjects with any cardiac implantable electronic devices, including loop recorders.
* Subjects with a wearable cardioverter defibrillator.
* Subjects with Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices.
* Subjects with any skin condition that would prevent them from wearing the µCor system.
* Subjects who are non-ambulatory.
* Subjects without adequate cellular transmission access that would prevent data download from the µCor device.
* Subjects participating in another clinical study.
* Subjects unable to give informed consent.
* Employees of ZOLL or their family members.
* Subjects traveling during the study participation period that prevents planned office visits and weekly phone calls from the study coordinator.
* Subjects expected to undergo a planned MRI exam during the participation period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04512703
Study Brief:
Protocol Section:
NCT04512703