Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06155643

EKO SENSORA: Detecting Clinically Significant Murmurs

Led by Corewell Health South · Updated on 2025-12-12

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the Eko SENSORA device, which uses artificial intelligence to detect clinically significant heart murmurs. This device records heart sounds via a digital stethoscope and analyzes them with machine learning to identify abnormalities. The study focuses on patients presenting with symptoms such as chest pain, fatigue, shortness of breath, or syncope, which can indicate heart problems. The goal is to improve detection of valvular heart disease in an emergency department setting. Participants will have their heart sounds recorded using the Eko SENSORA device placed on key areas of the chest for 15 to 30 seconds until a green light signals a good recording. The sounds are uploaded via Wi-Fi to an AI system that analyzes them without patient identifiers. The device then indicates if a significant heart murmur is present and specifies the recording location. This is an interventional study where the device's performance is being assessed. During the study, participants will be monitored for an average of 90 days to measure the number of new clinically significant heart murmurs detected. Researchers will also track the number of echocardiograms ordered. The study involves patients with cardiac risk factors and symptoms suggesting possible heart dysfunction. The device’s results and related clinical decisions will be recorded to assess its usefulness in the emergency department setting.

CONDITIONS

Brief Title

EKO SENSORA: Detecting Clinically Significant Murmurs

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Presenting with chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope
  • Patients with weakness are eligible if over 50 years old and have at least two of hypertension, BMI ≥ 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/transient ischemic attack, prior cardiac surgery, or angiography
Not Eligible

You will not qualify if you...

  • Patients under contact isolation
  • Pediatric patients under 18 years old

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Approximately 90 days

Participants are monitored to detect clinically significant heart murmurs using the Eko Sensora device over an average of 90 days.

Participants have heart sound recordings taken during usual care; no specific visit schedule is required.

Trial Site Locations

Total: 1 location

1

Corewell Health Lakeland

Saint Joseph, Michigan, United States, 49085

Actively Recruiting

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Research Team

M

Monique Luna, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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