NCT06938412 Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
| NCT ID | NCT06938412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-06-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Janice Y Chyou, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06938412 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938412 currently recruiting?
Yes, NCT06938412 is actively recruiting participants. Contact the research team at EASE-AF@mountsinai.org for enrollment information.
Where is the NCT06938412 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06938412 clinical trial?
NCT06938412 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Janice Y Chyou, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 120 participants.
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