Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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
Qualifiers
≥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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Physical Activity Intervention Using FitBit Wearable Device
Treatment groups
120 Participants
are divided into 1 treatment groupSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov