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RECRUITING
NCT07270692

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

Sponsor: Eko Devices, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-08-01

Completion Date

2026-11-01

Last Updated

2025-12-18

Healthy Volunteers

Yes

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.

Locations (1)

P. D. Hinduja Hospital and Medical Research Centre

Mumbai, Maharashtra, India