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EKO SENSORA: Detecting Clinically Significant Murmurs

EKO SENSORA: Detecting Clinically Significant Murmurs

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06155643
Acronym
EkoNM
Enrollment
300
Registered
2023-12-04
Start date
2023-10-26
Completion date
2027-07-26
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Murmurs

Keywords

eko, heart murmur, ai, machine learning, heart murmur detection

Brief 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.

Interventions

DEVICEEko 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

Corewell Health South
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Use of the Eko device

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of new clinically significant heart murmurs detectedthrough study completion, an average of 90 days

Secondary

MeasureTime frame
Number of echocardiograms orderedthrough study completion, an average of 90 days

Countries

United States

Contacts

CONTACTMonique Luna, MS
monique.allen@corewellhealth.org2699838679

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026