Detection of Heart Conditions Using Artificial Intelligence

Sponsor
Eko Devices, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04933890
Collaborator
(none)
300
1
3
99.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Use of Eko DUO electronic stethoscope

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Real-World Evaluation of the Performance of Eko's Heart Murmur Detection Algorithm When Used by Front-line Healthcare Providers on Geriatric Patients
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Outcome Measures

Primary Outcome Measures

  1. Single-lead ECG based algorithm development [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parker Jewish Institute of Health Care and Rehabilitation New Hyde Park New York United States 11040

Sponsors and Collaborators

  • Eko Devices, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eko Devices, Inc.
ClinicalTrials.gov Identifier:
NCT04933890
Other Study ID Numbers:
  • 2021.5
First Posted:
Jun 22, 2021
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021