EKO SENSORA: Detecting Clinically Significant Murmurs

Conditions

• Heart Murmurs

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Oct 26, 2023

Status verified

Dec 2025

Primary completion

Jul 26, 2026

Completion

Jul 26, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

• Other: Eko Device
  Patients with cardiac risk factors

Primary Outcome Measure

Number of new clinically significant heart murmurs detected [ Time Frame: through study completion, an average of 90 days ]

Central Contacts

• Monique Luna, MS
  2699838679
  [email protected]

Locations (1)

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