Detection of Heart Conditions Using Artificial Intelligence

NCT04933890 | Completed

• 1 other identifier: 2021.5
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Dysfunction; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Single-lead ECG based algorithm development

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

  Within two minutes of device use

• Single-lead ECG based algorithm Performance

  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

  Within two minutes of device use

Interventions

Use of Eko DUO electronic stethoscope DEVICE

Auscultation of heart sounds using electronic stethoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing a transthoracic echocardiogram will be enrolled. Patients who are over the age of 60 or who are at risk for heart failure (hypertension, murmur, etc.) will be targeted for enrollment. We will also target patients with a referral diagnosis of dyspnea on exertion, orthopnea, lower extremity edema, and possible heart failure.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (1)

Parker Jewish Institute of Health Care and Rehabilitation

New Hyde Park, New York, 11040, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Heart Failure

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 22, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)