Heart DiseaseNCT07351656
A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound
A study testing Focused Cardiac Ultrasound, 6-Lead AI-ECG and 12-Lead AI-ECG in people with Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- Focused Cardiac Ultrasound, 6-Lead AI-ECG and 12-Lead AI-ECG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,300 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to Feb 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrollment in a high-school, college or a resident in MN during the study period
- Age 18-29 years
- Informed consent (and assent for minors)
- Adult patients (>30 years of age, with pre-specified subgroups 30-64 and 65+))
- Adult female aged 18 to 49 years
- Pregnant at the time of enrollment
- Receiving obstetric care at identified study site(s)
- Willing and able to provide informed consent
Who cannot join
- Presence of a pacemaker or defibrillator
- Inability to obtain a quality ECG tracing
- Community dwelling adults:
- Inability to provide informed consent to participate in the study
- Pregnant women:
- Inability to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amanda Priebe, 507-422-6932, Priebe.Amanda@mayo.edu
Paul Friedman, MD
About this study
Official title: Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.
A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.
- Conditions
- Heart Disease
- Being tested
- Focused Cardiac Ultrasound, 6-Lead AI-ECG, 12-Lead AI-ECG
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused Cardiac UltrasoundDiagnostic test
Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.
6-Lead AI-ECGDiagnostic test
A 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives.
12-Lead AI-ECGDiagnostic test
A standard 12-lead ECG consists of 12 leads: 6 limb leads and 6 chest (precordial) leads. These leads record the heart's electrical activity from different angles to provide a comprehensive assessment of cardiac function.
| Study group | Role | What they receive |
|---|---|---|
| Community dwelling adults | Experimental | Not described Receives: Diagnostic Test: Focused Cardiac Ultrasound; Diagnostic Test: 6-Lead AI-ECG; Diagnostic Test: 12-Lead AI-ECG |
| Pregnant women | Experimental | Not described Receives: Diagnostic Test: Focused Cardiac Ultrasound; Diagnostic Test: 6-Lead AI-ECG; Diagnostic Test: 12-Lead AI-ECG |
| Adolescents and young adults | Experimental | Not described Receives: Diagnostic Test: Focused Cardiac Ultrasound; Diagnostic Test: 6-Lead AI-ECG; Diagnostic Test: 12-Lead AI-ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)
The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.
Measured: Baseline
Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults)
Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF <50%, >moderate right ventricular systolic dysfunction, >moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure > 50 mmHg), or elevated left-sided filling pressure.
Measured: Baseline
Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women)
Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction [LVEF] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension [right ventricular systolic pressure > 50 mmHg], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.
Measured: Baseline
Secondary outcomes (9)
Number of false positive AI-ECG Results (Adolescents and young adults)
Number of false positive AI-ECG results will be determined by the number of positive AI-ECG results proven false from an echocardiography
Measured: Baseline
Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)
The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM
Measured: Baseline
Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)
The number of positive AI-ECG results for CHD will be based on how many patient ECGs indicate a possible diagnosis of CHD
Measured: Baseline
Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)
Proportion of patients by age group (30-39, 40-49, 50-65, 65-74, and 75 years and older) to receive a diagnosis from ultrasound that is confirmed by a comprehensive diagnostic work up.
Measured: Baseline
Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG will be determined by the number of patients to have a correct diagnosis using the 6 lead ECG confirmed by echocardiogram compared to the total number of patients.
Measured: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG confirmed by echocardiogram compared to the total number of patients.
Measured: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG with adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.
Measured: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults)
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG without adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.
Measured: Baseline
Number of non-cardiac adverse events (Pregnant Women)
Number of non-cardiac adverse events can include hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, eclampsia), preterm delivery, gestational diabetes, small for gestational age delivery, placental abruption, and pregnancy loss.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start9 Mar 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 19,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul A. Friedman, Mayo Clinic
- Investigators
- Paul Friedman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351656
- Sponsor's protocol ID
- 25-012252
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Heart Disease Using AI-Enabled Electrocardiography and Focused Cardiac Ultrasound: the AI CVD Screen Study.
- ClinicalTrials.gov ID
- NCT07351656
- Acronym / sponsor ID
- 25-012252
- Conditions
- Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19,300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 20 Jan 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.
A study to evaluate feasibility, diagnostic yield, accuracy, and actionable thresholds of POC, immediate-feedback AI-ECG + AI FoCUS screening for cardiac disease in well described community populations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Community dwelling adults | Experimental | Diagnostic Test: Focused Cardiac Ultrasound, Diagnostic Test: 6-Lead AI-ECG, Diagnostic Test: 12-Lead AI-ECG |
| Pregnant women | Experimental | Diagnostic Test: Focused Cardiac Ultrasound, Diagnostic Test: 6-Lead AI-ECG, Diagnostic Test: 12-Lead AI-ECG |
| Adolescents and young adults | Experimental | Diagnostic Test: Focused Cardiac Ultrasound, Diagnostic Test: 6-Lead AI-ECG, Diagnostic Test: 12-Lead AI-ECG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Enrollment in a high-school, college or a resident in MN during the study period
- Age 18-29 years
- Informed consent (and assent for minors)
- Adult patients (>30 years of age, with pre-specified subgroups 30-64 and 65+))
- Adult female aged 18 to 49 years
Key exclusion criteria (6 listed)
- Presence of a pacemaker or defibrillator
- Inability to obtain a quality ECG tracing
- Inability to provide informed consent to participate in the study
- Inability to provide consent
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 |
|---|---|---|
| Focused Cardiac UltrasoundFocused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities. | Diagnostic test | Adolescents and young adults, Community dwelling adults, Pregnant women |
| 6-Lead AI-ECGA 6-lead ECG uses six electrodes placed on the chest and limbs to record the heart's electrical activity from multiple perspectives. | Diagnostic test | Adolescents and young adults, Community dwelling adults, Pregnant women |
| 12-Lead AI-ECGA standard 12-lead ECG consists of 12 leads: 6 limb leads and 6 chest (precordial) leads. These leads record the heart's electrical activity from different angles to provide a comprehensive assessment of cardiac function. | Diagnostic test | Adolescents and young adults, Community dwelling adults, Pregnant women |
Primary outcome
Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults)
Time frame: Baseline
The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.
Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults)
Time frame: Baseline
Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF <50%, >moderate right ventricular systolic dysfunction, >moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure > 50 mmHg), or elevated left-sided filling pressure.
Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women)
Time frame: Baseline
Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction [LVEF] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension [right ventricular systolic pressure > 50 mmHg], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.
9 secondary outcomes
Number of false positive AI-ECG Results (Adolescents and young adults)
Time frame: Baseline
Number of positive AI-ECG results for hypertrophic cardiomyopathy (HCM) (Adolescents and young adults)
Time frame: Baseline
Number of positive AI-ECG results for congenital heart defect (CHD) (Adolescents and young adults)
Time frame: Baseline
Proportion of patients by age group to receive a diagnosis (Community Dwelling Adults)
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG (Community Dwelling Adults)
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG (Community Dwelling Adults)
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS (Community Dwelling Adults)
Time frame: Baseline
Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS (Community Dwelling Adults)
Time frame: Baseline
Number of non-cardiac adverse events (Pregnant Women)
Time frame: Baseline
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Paul Friedman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused Cardiac Ultrasound, 6-Lead AI-ECG and 12-Lead AI-ECG in people with Heart Disease, run by Mayo Clinic 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Aug 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?
Contact Amanda Priebe (507-422-6932, Priebe.Amanda@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults) (time frame: Baseline). 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?
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 20 Aug 2026.