Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms (AFRESHE)

March 9, 2026 updated by: Shaan Khurshid, Massachusetts General Hospital

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Mass General Brigham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women aged 50-90 who are new or established patients in an MGH primary care or ambulatory cardiology practice
  • Willing to provide consent to participate in the study to access data from electronic health records (EHR)
  • At least 1 12-lead ECG obtained within 5 years prior to study start date for AF risk estimation
  • Have access to a smart phone or tablet to use with the AliveCor KardiaMobile 1L ECG device

Exclusion Criteria:

  • History of atrial fibrillation or atrial flutter as documented in the patient's current electronic health record medical problem list or self-reported diagnosis
  • Implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders)
  • History of allergy to adhesive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-risk
Low estimated risk for AF (<1% 1-year AF risk)
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.
Active Comparator: High-risk
Low estimated risk for AF (>10% 1-year AF risk)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New AF diagnosis (%)
Time Frame: 1 year
Rate of new AF diagnosis
1 year
Acceptability and usefulness
Survey-based acceptability and usefulness of 1L ECG screening process
AI-based AF risk correlation
Correlation between 12-lead ECG-based AF risk and 1L ECG-based AF risk using AI model

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P002767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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