NCT06155643

EKO SENSORA: Detecting Clinically Significant Murmurs

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Corewell Health South · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2023-10-26
• Primary completion: 2026-07-26
• Completion: 2026-07-26
• First posted: 2023-12-04
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study