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NCT Number: NCT06155643

EKO SENSORA: Detecting Clinically Significant Murmurs

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.

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Key information

Conditions

Heart Murmurs Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of new clinically significant heart murmurs detected

    Time frame: through study completion, an average of 90 days

Secondary outcomes

  1. Number of echocardiograms ordered

    Time frame: through study completion, an average of 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Monique Luna, MS

CONTACT

[email protected]

2699838679

Sponsors and collaborators

Lead sponsor

Corewell Health South

Other

Registry information

Acronym: EkoNM

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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