Recruiting

Observational Study

Sponsor:

Corewell Health South

Code:

NCT06155643

Conditions

Heart Murmurs

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eko Sensora

Study Details

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

Study ID

NCT06155643

Start date

Oct 26, 2023

Status verified date

Jul, 2026

Completion date

Jul 26, 2027

Anticipated

Primary completion date

Jul 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Eko Device

Patients with cardiac risk factors

Interventions

Eko 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Monique Luna, MS

2699838679monique.allen@corewellhealth.org

Locations

Corewell Health Lakeland

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Amanda Borchardt, PhD

2699838679amanda.borchardt@corewellhealth.org

Matthew Hysell, MD

matthew.hysell@corewellhealth.org

More Information

Sponsor

Corewell Health South

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • eko
  • heart murmur
  • ai
  • machine learning
  • heart murmur detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Corewell Health South on 2026-07-20.