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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT06938412
Eligibility Criteria:
Inclusion Criteria:
* ≥40years of age
* Paroxysmal AF
* Electrocardiographic (or equivalent) documentation of AF within 12 months (would need to have evidence of AF after initial post-ablation blanking period if the patient had prior AF ablation)
* AF Severity Scale (AFSS) symptom score 13-26
* Self-report weekly moderate-vigorous physical activity (MVPA) 30-120 minutes
Exclusion Criteria:
* Unable to give consent
* ≤90 days from AF ablation, coronary revascularization, heart failure hospitalization
* Left ventricular ejection fraction (LVEF) \<50%, moderate to severe stenotic valvular heart disease or severe regurgitant valvular disease or history of mechanical valve replacement, presence of implanted pacemaker or defibrillator system
* Labile INR or unable to take anticoagulant despite indication
* Life expectancy \< 1 year
* Hemodialysis; severe pulmonary or liver disease
* Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise
* Self-report MVPA \<30 minutes
* Upon initial screening, if the participant's baseline FitBit-measured MVPA ≥180 minutes/week (despite self-report range of 30-120 minutes), the participant will be further excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06938412
Study Brief:
Protocol Section:
NCT06938412