NCT04400435

Brief Summary

The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left ventricular EF.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,258

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

May 19, 2020

Last Update Submit

December 7, 2022

Conditions

Left Ventricular Dysfunction

Keywords

Ejection Fractionmachine learning

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Use of Eko DUO electronic stethoscopeDEVICE

Auscultation of heart sounds using electronic stethoscope

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Los Alamitos Cardiovascular

Los Alamitos, California, 90720, United States

Location

MedStar Cardiovascular Network

Washington D.C., District of Columbia, 20010, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

May 19, 2020

First Posted

May 22, 2020

Study Start

July 15, 2020

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

December 9, 2022

Record last verified: 2022-12

Locations

US(3)