Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence

December 10, 2025 updated by: Eko Devices, Inc.
The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400016
        • Recruiting
        • P. D. Hinduja Hospital and Medical Research Centre
        • Contact:

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

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will employ an all-comers strategy, indicating that virtually any patient who receives a standard-of-care echocardiogram may participate. The echocardiogram must be within 7 days of the CORE 500 measurements to ensure that the measured ejection fraction is contemporaneous with the heart sounds and 3-lead ECG. This will include both healthy patients and patients with low EF.

Description

Inclusion Criteria:

  • Adults aged 18 years and older
  • Able and willing to provide informed consent
  • Complete a clinical echocardiogram within 7 days before or after study procedures

Exclusion Criteria:

  • Unwilling or unable to provide informed consent
  • Patients who are hospitalized

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm
Time Frame: 15-16 months
The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.
15-16 months

Collaborators and Investigators

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

Sponsor

Eko Devices, Inc.

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)

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Estimated)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025.5

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

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.

Clinical Trials on Low Ejection Fraction

Clinical Trials on Eko digital stethoscopes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe