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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT04971993
Eligibility Criteria:
Inclusion Criteria:
* Subject is 18 years or older
* Willing and capable to provide written informed consent and agrees to participate in all protocol required activities
* Subjects must meet one of the following criteria:
* Documented New York Heart Association (NYHA) class II or III heart failure within the last 6 months
OR
* Subjects that have a known heart condition (non-heart failure) and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain and/or shortness of breath
Exclusion Criteria:
* Not able to walk continuously for a period of 6 minutes at the subjects baseline walking speed
* Prior hospitalization or surgery that affects the subjects baseline walking speed at time of enrollment
* Cardiovascular event such as unstable angina or myocardial infarction that affects the subjects baseline walking speed at time of enrollment
* Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system
* Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
* Subject is pregnant as indicated by subject report and/or medical record at the time of enrollment
* Subjects with rash or open wound on torso locations where investigational devices will be placed
* Have an active implantable device
* Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator
* Any medical signs or symptoms that in the opinion of the investigator could represent a risk for the subject (I.e. increased baseline blood pressure or heart rate).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04971993
Study Brief:
Protocol Section:
NCT04971993