EKO SENSORA: Detecting Clinically Significant Murmurs (EkoNM)

December 5, 2025 updated by: Corewell Health South

The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).

The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.

The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Locations

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:

  • Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
  • Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography

Exclusion Criteria:

  • Contact isolation patients
  • Pediatric patients under the age of 18

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eko Device
Patients with cardiac risk factors
Device: Eko Sensora
The exam involves placing the stethoscope in the aortic, pulmonic, tricuspid, and mitral areas for 15-30 seconds until a green light is displayed indicating that useful sound has been recorded. The recording is then uploaded by the device using wi-fi to the AI program for analysis. It does not carry patient identifiers. The device then indicates whether a clinically significant heart murmur was heard, and if so in which recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of new clinically significant heart murmurs detected
Time Frame: through study completion, an average of 90 days
through study completion, an average of 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of echocardiograms ordered
Time Frame: through study completion, an average of 90 days
through study completion, an average of 90 days

Collaborators and Investigators

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

Sponsor

Corewell Health South

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)

October 26, 2023

Primary Completion (Estimated)

July 26, 2026

Study Completion (Estimated)

July 26, 2026

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1635

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.

Yes

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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