Clinical Trial

Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms

Study acronym: AFRESHE
Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
The goal of this prospective, non-randomized pilot study is to learn whether predictions from a previously validated 12-lead ECG-based artificial intelligence (AI) algorithm (ECG-AI) identify people more likely to have undiagnosed atrial fibrillation (AF). The main questions it aims to answer are: Do people predicted to have high risk of AF using ECG-AI have a higher rate of new AF diagnosis using 1L ECG screening compared with people predicted to have a low risk? Do AI-based AF risk estimates from the 12-lead ECG correlate with AF risk estimates from the 1L ECG? Do people find 1L ECG screening for AF acceptable and useful? Participants will: Undergo screening with 1L ECG mailed to their home Complete a survey assessing attitudes toward 1L ECG screening Complete a 14-day patch monitor on 1 or 2 occasions depending on 1L ECG results
Trial Details
NCT Number NCT07468123
Lead Sponsor Massachusetts General Hospital
Conditions Atrial Fibrillation (AF)
Enrollment 200 participants
Start Date 2025-07-30
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-12