Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence

NCT07270692 | Recruiting

• 1 other identifier: 2025.5
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.

Conditions

Low Ejection Fraction

Keywords

low ejection fraction

Outcome Measures

Primary Outcomes (1)

• Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm

  The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.

  15-16 months

Interventions

Eko digital stethoscopes DEVICE

Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.

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

The study will employ an all-comers strategy, indicating that virtually any patient who receives a standard-of-care echocardiogram may participate. The echocardiogram must be within 7 days of the CORE 500 measurements to ensure that the measured ejection fraction is contemporaneous with the heart sounds and 3-lead ECG. This will include both healthy patients and patients with low EF.

You may qualify if:

• Adults aged 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)

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

RECRUITING

Central Study Contacts

Clinical Research Associate

CONTACT

8443563384; jackrin.walsh@ekohealth.com

Study Design

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

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)