NCT06938412Recruiting
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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 burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adoption. The growth of technology-driven health care and diagnostics, recognized as an emerging priority by the American Heart Association, offers an opportunity for a pragmatic and patient-centered approach to meet this need. EASE-AF is a prospective, interventional study with a sequential run-in control to evaluate if a digital health-driven, patient-centered exercise intervention improves AF symptoms and burden. The research team will enroll 120 patients with symptomatic, paroxysmal AF. The main impact of this study will be the establishment of evidence for a novel, pragmatic paradigm for a patient-centered, digital technology-driven personalized exercise intervention for patients with AF.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 14 Apr 2025
- Start date
- 11 Aug 2026
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Atrial fibrillation
- NCT number
- NCT06938412
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 11 Aug 2026 to the primary completion date, 31 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- ≤90 days from AF ablation, coronary revascularization, heart failure hospitalization
- Hemodialysis; severe pulmonary or liver disease
- Musculoskeletal, balance/gait issues, severe peripheral vascular disease, or neuropathy or other neurologic conditions limiting exercise
Lab values
- 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
Other
- Unable to give consent
- Life expectancy \< 1 year
- 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.
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.