EKO SENSORA: Detecting Clinically Significant Murmurs (EkoNM)

Spectrum Health - Lakeland

Status and phase: Enrolling; Early Phase 1

Conditions: Heart Murmurs

Treatments: Device: Eko Sensora

Study type: Interventional

Funder types: Other

Identifiers

NCT06155643

1635

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Eko Device

Other group

Description:

Patients with cardiac risk factors

Treatment:

Device: Eko Sensora