Atrial Fibrillation (AF)AFRESHENCT07468123
Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms
A study testing 1L ECG screening and Patch monitor in people with Atrial Fibrillation (AF), run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- 1L ECG screening and Patch monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
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
Read the 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)
- Being tested
- 1L ECG screening, Patch monitor
- Keywords
- atrial fibrillation, digital health, screening
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1L ECG screeningDiagnostic test
Individuals will undergo 1L ECG screening using the AliveCor KardiaMobile 1L ECG device
Patch monitorDiagnostic 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 group | Role | What they receive |
|---|---|---|
| Low-risk | Active comparator | Low estimated risk for AF (<1% 1-year AF risk) Receives: Diagnostic Test: 1L ECG screening; Diagnostic Test: Patch monitor |
| High-risk | Active comparator | Low estimated risk for AF (>10% 1-year AF risk) Receives: Diagnostic Test: 1L ECG screening; Diagnostic Test: Patch monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
New AF diagnosis (%)
Rate of new AF diagnosis
Measured: 1 year
Acceptability and usefulness
Survey-based acceptability and usefulness of 1L ECG screening process
Measured: 0
AI-based AF risk correlation
Correlation between 12-lead ECG-based AF risk and 1L ECG-based AF risk using AI model
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- High-risk versus low-risk comparison
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaan Khurshid, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468123
- Sponsor's protocol ID
- 2024P002767
- Acronym
- AFRESHE
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khurshid S, Friedman SF, Al-Alusi MA, Kany S, Sommers T, Anderson CD, Ho JE, McManus DD, Borowsky LH, Ashburner JM, Lubitz SA, Atlas SJ, Maddah M, Singer DE, Ellinor PT. Artificial intelligence-enabled analysis of handheld single-lead electrocardiograms to predict incident atrial fibrillation: an analysis of the VITAL-AF randomized trial. NPJ Digit Med. 2025 Nov 26;8(1):776. doi: 10.1038/s41746-025-02164-2.
PubMed 41299008Khurshid S, Friedman S, Reeder C, Di Achille P, Diamant N, Singh P, Harrington LX, Wang X, Al-Alusi MA, Sarma G, Foulkes AS, Ellinor PT, Anderson CD, Ho JE, Philippakis AA, Batra P, Lubitz SA. ECG-Based Deep Learning and Clinical Risk Factors to Predict Atrial Fibrillation. Circulation. 2022 Jan 11;145(2):122-133. doi: 10.1161/CIRCULATIONAHA.121.057480. Epub 2021 Nov 8.
PubMed 34743566
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Risk Estimation With Single-lead Handheld Electrocardiograms
- ClinicalTrials.gov ID
- NCT07468123
- Acronym / sponsor ID
- AFRESHE / 2024P002767
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, digital health, screening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- High-risk versus low-risk comparison
| Arm | Type | Receives |
|---|---|---|
| Low-risk | Active comparator | Diagnostic Test: 1L ECG screening, Diagnostic Test: Patch monitorLow estimated risk for AF (<1% 1-year AF risk) |
| High-risk | Active comparator | Diagnostic Test: 1L ECG screening, Diagnostic Test: Patch monitorLow estimated risk for AF (>10% 1-year AF risk) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1L ECG screeningIndividuals will undergo 1L ECG screening using the AliveCor KardiaMobile 1L ECG device | Diagnostic test | High-risk, Low-risk |
| Patch monitorIndividuals 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. | Diagnostic test | High-risk, Low-risk |
Primary outcome
New AF diagnosis (%)
Time frame: 1 year
Rate of new AF diagnosis
Acceptability and usefulness
Time frame: 0
Survey-based acceptability and usefulness of 1L ECG screening process
AI-based AF risk correlation
Time frame: 0
Correlation between 12-lead ECG-based AF risk and 1L ECG-based AF risk using AI model
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 41299008Khurshid S, Friedman SF, Al-Alusi MA, Kany S, Sommers T, Anderson CD, Ho JE, McManus DD, Borowsky LH, Ashburner JM, Lubitz SA, Atlas SJ, Maddah M, Singer DE, Ellinor PT. Artificial intelligence-enabled analysis of handheld single-lead electrocardiograms to predict incident atrial fibrillation: an analysis of the VITAL-AF randomized trial. NPJ Digit Med. 2025 Nov 26;8(1):776. doi: 10.1038/s41746-025-02164-2.
- Background: PubMed 34743566Khurshid S, Friedman S, Reeder C, Di Achille P, Diamant N, Singh P, Harrington LX, Wang X, Al-Alusi MA, Sarma G, Foulkes AS, Ellinor PT, Anderson CD, Ho JE, Philippakis AA, Batra P, Lubitz SA. ECG-Based Deep Learning and Clinical Risk Factors to Predict Atrial Fibrillation. Circulation. 2022 Jan 11;145(2):122-133. doi: 10.1161/CIRCULATIONAHA.121.057480. Epub 2021 Nov 8.
- Individual participant dataSharing planned: No
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1L ECG screening and Patch monitor in people with Atrial Fibrillation (AF), run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New AF diagnosis (%) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07468123, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.