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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 1, 2026 → Oct 2026
See other at-risk trials from Eko Devices, Inc.

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment resumed after suspension
    • Site details revised
    v4
  2. Recruitment suspended Sponsor's reason: Patient enrollment temporarily paused while DSA and Consulting Agreement contracts are renewed
    • Primary completion pushed from Aug 1, 2026 to Oct 2026
    • Site details revised
    v3
  3. Primary endpoint revisedv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07270692
Lead Sponsor Eko Devices, Inc.
Conditions
(from sponsor)		 Low Ejection Fraction
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov