Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07468123
Status
Enrolling By Invitation

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • 1L ECG screening — DIAGNOSTIC_TEST
    Individuals will undergo 1L ECG screening using the AliveCor KardiaMobile 1L ECG device
  • Patch monitor — DIAGNOSTIC_TEST
    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.

Study Details

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

Key Dates

Start date
Jul 30, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Low-risk
    Low estimated risk for AF (\<1% 1-year AF risk)
  • Active Comparator: High-risk
    Low estimated risk for AF (\>10% 1-year AF risk)

Primary Outcome Measure

New AF diagnosis (%) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mass General BrighamBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Mass General Brigham· Boston, MA

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