NCT07468123

Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a prospective, non-randomized pilot study designed to assess whether our 12-lead ECG algorithm can identify individuals with AF detectable using 1L ECG. We will also assess whether AF risk estimates from the 1L ECG correlate with those using the 12-lead ECG. We also plan to assess participant attitudes toward the use of 1L ECGs for AF risk estimation. Using our AF risk algorithm on existing 12-lead ECGs, will categorize prospective participants into low AF risk (\<1% 1-year AF risk) versus high AF risk (\>10% 1-year AF risk). We will mail 1L ECG devices to participants and ask them to obtain 3 tracings which we will then use to estimate AF risk using a 1L ECG version of our AF risk algorithm. We will then screen perform patch monitor screening for AF and compare the rates of AF detection between the two groups. This study involves use of two consumer digital devices. The AliveCor KardiaMobile 1L ECG device is an FDA cleared cardiac rhythm assessment device capable of producing a 1L ECG in conjunction with a compatible smartphone. The Zio®XT is an FDA cleared medical-grade 1L ECG rhythm monitor. This pilot study has three main outcomes: 1) prospectively ascertained estimated AF risk using the handheld 1L ECG algorithm, 2) incident AF at 12 months, ascertained using the linked EHR and/or the results of the study patch monitors, and 3) perceived acceptability and usefulness of the handheld ECG. No physical study visits are required according to this protocol.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	1L ECG screening	Individuals will undergo 1L ECG screening using the AliveCor KardiaMobile 1L ECG device
DIAGNOSTIC_TEST	Patch monitor	Individuals who are found to have evidence of AF on 1L ECG will undergo assessment with 14-day patch monitor at the time of initial screen. Otherwise all study participants will undergo 14-day patch monitor at the 1-year timepoint.

Timeline

• Start date: 2025-07-30
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-03-12
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States