EKO SENSORA: Detecting Clinically Significant Murmurs

Heart Murmurs Clinical Trial

— EkoNM  

Official title:

EKO SENSORA: Detecting Clinically Significant Murmurs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155643
• Other study ID #: 1635
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 26, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Spectrum Health - Lakeland
• Contact: Monique Luna, MS
• Phone: 2699838679
• Email: monique.allen[@]corewellhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Murmurs

Intervention

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.

Locations

Country	Name	City	State
United States	Corewell Health Lakeland	Saint Joseph	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Spectrum Health - Lakeland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of new clinically significant heart murmurs detected		through study completion, an average of 90 days
Secondary	Number of echocardiograms ordered		through study completion, an average of 90 days