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Clinical Trials in India / NCT07270692
Recruiting Observational

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

NCT07270692 · tracked via the Priya Life Science India tracker
Sponsor
Eko Devices, Inc
Phase
Observational
Started
2025-08-01
Last updated
2026-11-04

Condition(s) studied

Low Ejection Fraction

Investigational drug(s) / intervention(s)

Eko digital stethoscopes

Eko digital stethoscopes: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: * Unwilling or unable to provide informed consent * Patients who are hospitalized

Primary outcome measure(s)

  • Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm — 15-16 months
    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.

Trial sites (1)

FacilityCityRegionStatus
P. D. Hinduja Hospital and Medical Research Centre Mumbai Maharashtra Recruiting

More Eko Devices, Inc. trials in India

Data Collection Using Eko Devices in a Clinical Setting Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07270692 on ClinicalTrials.gov ↗ ← All trials in India