Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting

Heart Murmurs Clinical Trial

Official title:

Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176899
• Other study ID #: 2021.12
• Status: Recruiting
• Start date: March 11, 2022
• Est. completion date: November 2023

Study information

• Verified date: June 2023
• Source: Eko Devices, Inc.
• Contact: Cody Hitchcock, MSc
• Phone: 1-844-356-3384
• Email: cody.hitchcock[@]ekohealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur Analysis Software) on a clinician's referral decision in a real-world primary care setting. There is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram.

Description:

Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation. In June 2022, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko Murmur Analysis Software" (EMAS), a set of machine learning algorithms that are able to screen signal quality and identify fundamental heart sounds, distinguish structural murmurs from absent or innocent murmurs, and provide a structural murmur's timing in the cardiac cycle.

This study sets out to evaluate the impact of EMAS on a clinician's referral decision in a real-world primary care setting, with the additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram. Providers will receive access to the EMAS screening tool, called the SENSORA™ Disease Detection Platform, which features the FDA cleared 3M™ Littmann® CORE stethoscope paired with the FDA cleared SENSORA™ enterprise application and EMAS AI running on an iPad, which is mounted on a Tryten stand. SENSORA™ will be used by medical assistants or equivalent as part of the initial patient intake process (e.g., during vitals acquisition).

EMAS influence on individual providers will be assessed by reviewing each provider's number of referrals to cardiology and number of echocardiogram orders for the 6 months preceding study start. These values will be compared to cardiac referral and order rates at the end of the study. Patient outcomes data (e.g., cardiology appointment notes, echocardiogram findings, follow up visits scheduled) will be pulled 6 months after the patient is seen by their primary care provider. Secondary objectives include the continued assessment of algorithm performance on a point-of-care population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patient verbally consents to participation

• Patient is willing to have heart sounds recorded with an electronic stethoscope

• Patient is age 50 years or older

Exclusion Criteria:

• Patient is unwilling or unable to give verbal informed consent

• Patients experiencing a known or suspected acute cardiac event

• Patient is under the age of 50 years old

Related Conditions & MeSH terms

• Heart Murmurs
• Innocent Murmurs
• Murmur, Heart

Intervention

Device:
• Use of Eko CORE electronic stethoscope
Recording of heart sounds using electronic stethoscope

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eko Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of EMAS on echocardiogram order rates	Echocardiogram order rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole	01/17/2022 - 11/30/2023
Primary	Impact of EMAS on cardiologist consult order rates	Cardiology consultation referral rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole	01/17/2022 - 11/30/2023
Primary	Impact of EMAS on provider decision-making	Impact of EMAS on provider decision to refer to echocardiogram, cardiologist, or other workup related to cardiac murmur. Measured via a survey administered to each provider after each patient is screened, which asks if SENSORA AI influenced their decision to refer or not to refer. Measured for individual providers and aggregated for the site as a whole.	01/17/2022 - 11/30/2023
Secondary	Impact of EMAS on patient outcomes	VHD discovery rates before and after SENSORA platform implementation, for individual providers and aggregated for the site as a whole	01/17/2022 - 11/30/2023
Secondary	Sensitivity and specificity	EMAS' accuracy (sensitivity and specificity) in detecting structural murmur, compared to an annotator panel	01/17/2022 - 11/30/2023