A Multicenter Pragmatic Implementation Study of ECG-AI-Based Clinical Decision Support Software to Identify Low LVEF (AIM ECG-AI)

August 28, 2025 updated by: Anumana, Inc.

A Prospective Pragmatic Cluster-Randomized Care-as-Usual Controlled Study to Evaluate the Impact of an ECG-Based AI Algorithm to Detect Low Left Ventricular Ejection Fraction on Diagnosis Rates of LVEF ≤40% in the Outpatient Setting

A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting.

The objective of this study is to evaluate the impacts of an ECG-AI algorithm to detect low LVEF and an associated Medical Device Data System when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study is a prospective, cluster randomized, care-as-usual controlled trial that will be conducted at 6 sites in the USA.

Primary care clinicians and general cardiologists will be invited and consented to participate in the study. For clinicians that accept, practice groups will be randomized to receive access to and education about the Low EF AI-ECG software and encompassing software or to provide care-as-usual in the control group. The study will be conducted in two phases: a feasibility pilot to evaluate integration and usability followed by observational period(s) to evaluate clinical outcomes.

Analyses of the primary and secondary endpoints will be conducted on data from patients that meet the inclusion and exclusion criteria. The expected duration of the study is 12 months, including a feasibility phase (estimated 6 weeks) followed by a 3-month initial observation period with rolling observation count monitoring until the target number of patient encounters is reached, followed by a 90-day follow up period.

At the completion of the feasibility period, we will evaluate quantitative and qualitative outcomes to inform the following observational period(s).

Primary endpoints and exploratory endpoints will be assessed the end of the study.

Study Type

Interventional

Enrollment (Actual)

11610

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Health
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males and females 18 years or older (including females who are pregnant, breastfeeding and/or lactating)
  • Digital ECG captured or available within site for ECG-AI analysis at point-of-care

Exclusion Criteria:

  • Known history of LVEF ≤ 40%
  • Known history of systolic heart failure
  • Known history of heart failure with reduced ejection fraction
  • Opted out of electronic health record-based research

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anumana Low EF AI-ECG Algorithm
Device: Anumana Low EF AI-ECG Algorithm
Clinician will have access to the Anumana Low EF AI-ECG algorithm via a link in the patient's electronic health record which will display results applied to patients' ECGs, as well as supporting information. Using the results of the algorithm, combined with the clinician's knowledge of patient-specific risk factors, the clinician will determine whether further evaluation is warranted.
Other: Care-as-Usual
Other: Care-as-Usual
Clinicians will not have access to the Anumana Low EF AI-ECG algorithm and will provide care-as-usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
Time Frame: 90 days
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anumana, Inc.

Collaborators

Mayo Clinic

Investigators

  • Principal Investigator: Francisco Lopez-Jimenez, MD, MSc, MBA, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Actual)

May 30, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

May 1, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • DOC-244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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