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Recruiting NCT07270692

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

— Observational Low Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eko digital stethoscopes.
Who it may be relevant to
Registry conditions: Low Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm [Time frame: 15-16 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

India · 1 center
  • P. D. Hinduja Hospital and Medical Research Centre — Mumbai

Identifiers

NCT: NCT07270692 · 2025.5

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗