Recruiting

AI-ECG & AI FoCUS

Sponsor:

Mayo Clinic

Code:

NCT07351656

Conditions

Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Focused Cardiac Ultrasound

6-Lead AI-ECG

12-Lead AI-ECG

Study Details

Brief 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.

Conditions

Heart Disease

Study ID

NCT07351656

Start date

Mar 9, 2026

Status verified date

Apr, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Adolescents and young adults:

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Presence of a pacemaker or defibrillator
  • Inability to obtain a quality ECG tracing

Community dwelling adults:

Inclusion Criteria:

• Adult patients (>30 years of age, with pre-specified subgroups 30-64 and 65+))

Exclusion Criteria:

• Inability to provide informed consent to participate in the study

Pregnant women:

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Inability to provide consent

Study Design

Enrollment

19300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Community dwelling adults

experimental: Pregnant women

experimental: Adolescents and young adults

Interventions

Focused Cardiac Ultrasound

Focused cardiac ultrasound will utilize sonography to evaluate specific cardiac conditions, such as ventricular function, pericardial effusion, and valvular abnormalities.

6-Lead AI-ECG

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-ECG

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.

Primary outcome measure

  • Percentage of participants with positive AI-ECG findings confirmed by echocardiography (Adolescents and young adults) [ Time Frame: Baseline ]
  • Number of patients with positive AI-ECG detection for left-right sided SHD (Community Dwelling Adults) [ Time Frame: Baseline ]
  • Number of times the AI-ECG provides a correct diagnosis of clinically significant cardiac disease (Pregnant women) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Amanda Priebe

507-422-6932Priebe.Amanda@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amanda Priebe

507-422-6932Priebe.Amanda@mayo.edu

Principal Investigator:

Paul Friedman, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-20.