NCT07468123Enrolling by invitation
Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 30 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07468123
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 30 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mass General Brigham Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.