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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT03785418
Eligibility Criteria:
Inclusion Criteria:
* paroxysmal or persistent AFIB (in sinus rhythm at the time of randomization)
* BMI \> 30 kg/m\^2 or a waist circumference greater than 100 cm (male) or 90 cm (female)
* have daily access to an iPhone
* have at least one of the following risk factors:hypertension, diabetes or pre-diabetes, hyperlipidemia, smoker, obstructive sleep apnea
Exclusion Criteria:
* Permanent AFIB (AFIB lasting \> 1 year)
* Prior or actively on waiting list for catheter ablation for AFIB
* History of unstable angina not corrected with revascularization
* Left ventricular ejection fraction \<30%
* Left atrial size \>5.5 cm
* New York Heart Association (NYHA) classification IV heart failure
* Moderate or severe cardiac valvular lesion (stenosis or regurgitation) on echocardiography or valvular lesion requiring intervention.
* Participation in a cardiac rehabilitation program within the last year
* Serious underlying psychiatric disorder: e.g. eating disorder, severe psychotic disorder with recent (3 month) hospitalization or psychiatric illness requiring supervised care precluding full independent function.
* Participants who are unable or unwilling to provide fully informed consent.
* Currently performing exercise training 150 minutes/week of moderate to vigorous physical activity
* Gastrointestinal malabsorption disorder: A previously diagnosed gastrointestinal malabsorption disorder interfering with macro or micronutrient absorption.
* If receiving warfarin and unstable international normalized ratio (INR) defined as persistently outside of the therapeutic range (2.0-3.0) for greater than 14 consecutive days.
* Other non-cardiovascular medical conditions making 1-year survival unlikely.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03785418
Study Brief:
Protocol Section:
NCT03785418