Status:
RECRUITING
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
American Heart Association
Conditions:
Atrial Fibrillation
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and b...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06938412
Start Date
October 1 2025
End Date
March 31 2027
Last Update
October 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029