Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation (EASE-AF)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Joshua Wiener
EASE-AF@mountsinai.org
646-761-3506
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 120
Treatments
Experimental: Patients With Atrial Fibrillation
Patients with symptomatic, paroxysmal AF.
Related Therapeutic Areas
Sponsors
Collaborators: American Heart Association
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov

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