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OpenTrials
Completed

NCT Number: NCT04933890

Detection of Heart Conditions Using Artificial Intelligence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parker Jewish Institute of Health Care and Rehabilitation

New Hyde Park, New York, 11040, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English-speaking adults who are 18 years and older
  • Able and willing to provide informed consent
  • Complete a clinical echocardiogram within 7 days before or after study procedures

Exclusion criteria

  • Unwilling or unable to provide informed consent
  • Patients who are hospitalized

Treatment and study plan

Use of Eko DUO electronic Stethoscope

Device

Auscultation of heart sounds using electronic stethoscope

Primary outcomes

  1. Single-lead ECG based algorithm development

    Time frame: Within two minutes of device use

    Evaluate performance of single-lead ECG based algorithm to identify individuals with reduced ejection fraction.

  2. Single-lead ECG based algorithm Performance

    Time frame: Within two minutes of device use

    To demonstrate that Eko's murmur detection algorithm outperforms front-line healthcare providers in detecting heart murmurs in real-world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm detects murmurs in comparison to an 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 study

Sponsors and collaborators

Lead sponsor

Eko Devices, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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