Real-World Evaluation of Eko Algorithms in a Point of Care Setting

Atrial Fibrillation Clinical Trial

Official title:

Real-World Evaluation of Eko Algorithms in a Point of Care Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05459545
• Other study ID #: 2021.11
• Status: Recruiting
• Start date: April 15, 2022
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Eko Devices, Inc.
• Contact: Doug Van Pelt
• Phone: 1-844-356-3384
• Email: doug.vanpelt[@]ekohealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.

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 November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late.

Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021.

This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient consents to participation

• Willing to have heart sounds recorded with an electronic stethoscope

• Willing to undergo echocardiography

• Willing to undergo a 12-lead electrocardiogram

• Adults aged 65 years and older

• History of at least one of the following: hypertension, BMI = 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography

• No prior diagnosis of valve disease or heart murmur

Exclusion Criteria:

• Patient is unwilling or unable to give written informed consent

• Patients experiencing a known or suspected acute cardiac event

• Under the age of 65 years old

• Prior diagnosis of valve disease or heart murmurs

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Murmurs
• Innocent Murmurs
• Murmur, Heart

Intervention

Device:
• Use of Eko CORE and Eko CORE 500 electronic stethoscope
Auscultation of heart sounds using electronic stethoscopes

Locations

Country	Name	City	State
United States	Maria Medical Center	Dunn	North Carolina
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	Pentucket Medical Associates	Lawrence	Massachusetts
United States	Edgewater Medical Center	Lillington	North Carolina
United States	Hometown Medical PLLC	Lillington	North Carolina

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	Sensitivity and Specificity of Eko's AI relative to ground truth	Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.	02/20/2022 - 05/20/2024
Primary	Sensitivity and Specificity of Eko's AI relative to PCP auscultation and ground truth	Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth and PCP auscultation ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.	02/20/2022 - 05/20/2024
Primary	Positive and negative predictive values for AI detecting new VHD	Positive and negative predictive values of Eko's algorithms for detecting new clinically significant valvular heart disease	02/20/2022 - 05/20/2024
Primary	Positive and negative predictive values for PCP detecting new VHD	Positive and negative predictive values of a PCP's outpatient visit for detecting new clinically significant valvular heart disease	02/20/2022 - 05/20/2024
Secondary	Sensitivity and Specificity of Eko's AI relative to echocardiographic ground truth.	Sensitivity and specificity of Eko's murmur detection algorithm relative to echocardiographic ground truth.	02/20/2022 - 05/20/2024
Secondary	Performance of the machine algorithm vs. the physician	Performance of the machine algorithm vs. the physician	02/20/2022 - 05/20/2024
Secondary	Number of cardiac tests and consultations ordered	Number of cardiac tests and consultations ordered	02/20/2022 - 05/20/2024