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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Low Ejection Fraction

Keywords

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low ejection fraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Clinical Research Associate

Role: CONTACT

Phone: 8443563384

Email: [email protected]

Facility Contacts

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Principal Investigator

Role: primary

Other Identifiers

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2025.5

Identifier Type: -

Identifier Source: org_study_id