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Recruiting NCT06938412

Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation

Conditions: Atrial Fibrillation, Arrhythmias, Cardiac, Cardiovascular Diseases

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Icahn School of Medicine at Mount Sinai

Location: Icahn School of Medicine at Mount Sinai New York New York

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) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06938412). StuddyBuddy aggregates publicly available trial information.