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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT02825966
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female volunteers who are able to fit in the WCD garment (26 to 56 inches measured circumferentially at the level of the xiphoid process).
* Included in this group are at least five healthy subjects with a self-reported history of heart failure.
* The subject must be 18 years of age or older on the day of screening, with at least 7 subjects 40 years of age or older on the day of screening.
Exclusion Criteria:
* Mental, visual, physical, literacy, and auditory limitations that prevent interaction with the WCD equipment.
* Any acute medical conditions that prevent the following maneuvers: lying on back, lying on the right and left side, standing, sitting, and/ or leaning forward when sitting.
* Any self-reported shortness of breath, fatigue, swelling of feet, ankles, or legs, and/or chest pain
* Employees or family members of the sponsor.
* Unable or unwilling to provide written informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02825966
Study Brief:
Protocol Section:
NCT02825966