Low Ejection Fraction in Single Lead ECG- Ochsner

NCT05010642 | Completed

• 1 other identifier: 2021.4
• Study Type: observational
• Target: 307
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Dysfunction; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

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 Stethoscope DEVICE

Auscultation of heart sounds using electronic stethoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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)

Ochsner Heart and vascular Institute

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Salima Qamruddin, MD

  Ochsner Heart and Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: August 19, 2021
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)