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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT04703166
Eligibility Criteria:
Inclusion Criteria:
Participants must meet the following criteria to be enrolled in the trial:
* Participants with atrial fibrillation aged 18 to 79 years old, or
* Participants aged 40 to 79 years old, at moderate or high risk for CVD as defined by the 10-year risk Atherosclerotic Cardiovascular Disease (ASCVD), a validated risk calculation tool.
* Participants who have access to internet/e-mail in their homes.
* Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
* Participants who are able and willing to return to the study clinic one-year following their baseline CMR for a follow-up appointment and 12-month CMR.
* Participants who are able to read, understand, and sign the consent form.
Exclusion Criteria:
Participants will be excluded from enrollment if any of the following criteria are present:
* Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.).
* Participants weighing \>300 lbs. (MRI quality decreases as BMI increases).
* Participants with renal insufficiency (Glomerular Filtration Rate (GFR) \<30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease.
* Women who are pregnant at the time of enrollment/consent. (Should a participant become pregnant during the course of the study, no CMR will be performed until 10 days, postpartum).
* Participants who do not have access to the internet/e-mail.
* Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
* Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
* Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR.
* Participants with cognitive impairments who are unable to give informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04703166
Study Brief:
Protocol Section:
NCT04703166