NCT04933890

Detection of Heart Conditions Using Artificial Intelligence

Real-World Evaluation of the Performance of Eko's Heart Murmur Detection Algorithm When Used by Front-line Healthcare Providers on Geriatric Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 68 (actual)
• Sponsor: Eko Devices, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this study is to evaluate how Eko AI performs in the real world, front-line setting where the availability of sophisticated, expensive diagnostic tools is limited, and where there is a premium on detecting VHD early in its course.

Detailed description

Echocardiography is the state of the art for diagnosing VHD. However, without an effective pre-screening tool, many echocardiograms ("echos") are being ordered unnecessarily. A recent study found that greater than 66% of all echos performed in the United States do not alter clinical management, while an additional 4% may be deemed inappropriate altogether. Because of this, echos now make up a disproportionately large segment of healthcare expenditure. Each year, 1 in 5 Medicare enrollees receives an echo at a total cost of $1.2 billion, or 11% of total Medicare spending on imaging services. This is compounded by the fact that an estimated 35 million Americans live in medically underserved areas, where patients must travel an average of 56 miles to see a specialist and receive an echo. This does not encourage compliance, and only adds to cost, lost working hours, and inconvenience. There is therefore a growing, unmet need for better VHD screening tools. Tools that will consistently, reliably, quickly, and cheaply identify VHD when it is early and asymptomatic, when patients can be managed early and appropriately, and when they are at the lowest risk from an intervention. Such a tool will have a positive impact on the cost of care, patient and provider experience, and healthcare outcomes. The FDA-cleared Eko CORE and Eko DUO electronic stethoscopes offer clinicians a familiar and inexpensive tool that is widely accepted by patients and providers, while at the same time offer sensors and artificial intelligence technology that can improve screening and detection of medical conditions such as VHD. Both the CORE and the DUO feature sound amplification during auscultation - the CORE also offers active noise cancellation - which improves the ability of the clinician to detect nuanced changes in heart sounds.

Conditions

• Left Ventricular Dysfunction
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Use of Eko DUO electronic stethoscope	Auscultation of heart sounds using electronic stethoscope

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-06-22
• Last updated: 2022-12-09

Locations

1 site across 1 country: United States