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 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT04634461
Eligibility Criteria:
Inclusion Criteria:
* Patients (male and female) between 21 - 75 years of age
* Patients of both sexes, of varying races and ethnicities, with a range of educational levels and ages
* ICD-10 diagnosis code of PAF in the electronic medical record or ECG demonstrating PAF in the chart.
* History of PA symptoms as identified on screening with the PHQ-PD
* Read and speak English
* Access to a smartphone and internet/data coverage.
* Ability to read and type within a smartphone-based application.
* Capacity to understand and provide informed consent, and comply with protocol requirements that includes completion of a limited number of questionnaires.
Exclusion Criteria:
* Uncontrolled hypertension (defined as documented BP readings consistently above 140/90)
* Patients younger than 21 years old or older than 75 years old
* Reversible causes of AF, which include but are not limited to untreated thyroid disease, recent major surgical procedure or trauma, etc
* History of persistent or chronic AF
* History of clinically significant valvular heart disease (bio prosthetic or mechanical valve, severe aortic stenosis, moderate to severe mitral stenosis, rheumatic heart disease, or severe mitral regurgitation)
* History of congestive heart failure (CHF) and an ejection fraction (EF) of less than 40%
* History of new onset coronary artery disease (CAD) in the last 90 days
* History of myocardial infarction (MI) in the last 90 days
* History of percutaneous coronary intervention in the last 90 days
* History of coronary artery bypass grafting in the last 90 days.
* History of untreated obstructive sleep apnea (OSA)
* History of severe pulmonary hypertension
* Patients on rhythm control medications and expected to have changing dose during the study (not excluded if patient anticipated to be on stable dose throughout duration of the study: 30 days).
* History of cerebrovascular injury (stroke, transient ischemic attack, traumatic brain injury) in the last 90 days
* Morbid obesity, Body Mass Index (BMI) \>40 kg/m2
* Dementia or any form of cognitive impairment that precludes the patient from providing consent
* Pregnant women
* Patients with a major psychiatric disorder which, in the opinion of the investigator, may impede his/her participation in the study. These disorders include, but are not limited to, major depression with high likelihood of suicidal behavior (i.e., intent or plan), alcohol or substance abuse/dependence within the past year, lifetime history of schizophrenia or schizoaffective disorder, psychoses, mania.
* Patients who do not have a smartphone device
* Uncompensated hearing or visual defects
* Patients unable to communicate verbally in English
* Patients who are unable to fully comprehend the consent forms
* Medically unstable patients or patients who have a life expectancy less than the anticipated duration of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT04634461
Study Brief:
Protocol Section:
NCT04634461