EKO SENSORA: Detecting Clinically Significant Murmurs

NCT06155643 | Recruiting FDA Device

• 1 other identifier: 1635
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Murmurs

Keywords

eko; heart murmur; ai; machine learning; heart murmur detection

Outcome Measures

Primary Outcomes (1)

• Number of new clinically significant heart murmurs detected

  through study completion, an average of 90 days

Secondary Outcomes (1)

• Number of echocardiograms ordered

  through study completion, an average of 90 days

Study Arms (1)

Eko Device

OTHER

Patients with cardiac risk factors

Device: Eko Sensora

Interventions

Eko Sensora DEVICE

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.

Eko Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Corewell Health Lakeland

Saint Joseph, Michigan, 49085, United States

RECRUITING

MeSH Terms

Conditions

Heart Murmurs

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Monique Luna, MS

CONTACT

2699838679; monique.allen@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Use of the Eko device

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: December 4, 2023
• Study Start: October 26, 2023
• Primary Completion (Estimated): July 26, 2026
• Study Completion (Estimated): July 26, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)