Clinical Trial

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

Recruiting
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Record status
This record was last updated December 18, 2025 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-26.
Trial Details
NCT Number NCT07270692
Lead Sponsor Eko Devices, Inc.
Conditions Low Ejection Fraction
Enrollment 500 participants
Start Date 2025-08-01
Primary Completion 2026-08-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-18