Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms
Enrolling by invitation · Not applicable
Conditions studied: Atrial Fibrillation (AF)
In brief
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 facts
- Study ID
- NCT07468123
- Run by
- Massachusetts General Hospital
- People needed
- 200
- Starts
- 2025-07-30
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-03-12
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mass General Brigham — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.