Recruiting

AI-Enabled Electrocardiograms for Aortic Stenosis and Diastolic Dysfunction Diagnosis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Aortic Valve Disease+3

+ Aortic Valve Stenosis

+ Cardiovascular Diseases

Over 60 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2024
See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactLevi DisrudMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 8, 2024

Actual date on which the first participant was enrolled.

Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.

Official TitleThe Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
NCT06580158
Principal SponsorMayo Clinic
Study ContactLevi DisrudMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow Obstruction

Criteria

1 inclusion criteria required to participate
≥ 60 years of age must have a clinical scheduled ECG performed.
3 exclusion criteria prevent from participating
59 years of age
Is not scheduled for a clinical ECG
Unable to provide consent.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
Recruiting
One Study Center