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EKO SENSORA: Detecting Clinically Significant Murmurs

NCT06155643 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-12

No results posted yet for this study

Summary

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.

Conditions

  • Heart Murmurs

Interventions

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.

Sponsors & Collaborators

  • Corewell Health South

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2026-07-26
Completion
2026-07-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06155643 on ClinicalTrials.gov