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OpenTrials
Suspended

NCT Number: NCT07270692

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

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.

Why the study stopped: Patient enrollment temporarily paused while DSA and Consulting Agreement contracts are renewed
Suspended

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Key information

Conditions

Low Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, 400016, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eko Devices, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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