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Recruiting Not applicable

Relevance of Artificial Intelligence-Assisted Echocardiography for Left Ventricular Ejection Fraction Assessment in Geriatric Patients

NCT07701369 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2026-07-07
Last updated
2026-07-28

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

AutoEF-AI AssessmentStandard Echocardiography (Reference method)

AutoEF-AI Assessment: Performed by a geriatrician who has completed a one-day practical training session and combines: * A handheld ultrasound device providing real-time image acquisition guidance for obtaining apical views. * Us2.ai software for automated LVEF analysis. The geriatrician is blinded to results of the gold standard echocardiography performed by the cardiologist.

Standard Echocardiography (Reference method): The standard echocardiography will be performed by an expert cardiologist as part of routine clinical care and will serve as the gold standard

Study summary

Heart failure (HF) is the leading cause of hospitalization among adults aged 80 years and older and represents a major diagnostic challenge in geriatric medicine due to frequently atypical clinical presentations and the presence of multiple comorbidities. Although transthoracic echocardiography (TTE) with measurement of left ventricular ejection fraction (LVEF) remains the gold standard for cardiac functional assessment, access to echocardiography is often limited in geriatric wards.

Recent advances in artificial intelligence (AI) have enabled the development of portable ultrasound devices and automated image analysis software capable of providing reliable and reproducible LVEF measurements. AI-assisted automated LVEF assessment (AutoEF-AI) may therefore represent a valuable alternative to conventional echocardiography for the cardiac evaluation of older patients with heart failure.

Eligibility

Sex
ALL
Min age
75 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥75 years. * Hospitalization in a geriatric unit for acute heart failure according to the 2021 ESC diagnostic criteria. * Hemodynamic stability at the time of echocardiographic examination. * Ability to understand study information, provide written informed consent, and willingness to participate. * Affiliation with, or beneficiary of, a health insurance/social security scheme. Exclusion Criteria: * Hemodynamic instability preventing echocardiographic assessment. * Contraindication to transthoracic echocardiography. * Patients under legal protection (guardianship, curatorship, or judicial protection measures) or unable to provide informed consent. * Refusal to participate in the study.

Primary outcome measure(s)

  • Agreement between LVEF measured using AutoEF-AI and LVEF measured using standard echocardiography. — At baseline
    Agreement will be assessed using: * Intraclass Correlation Coefficient (ICC) * Spearman correlation coefficient * Bland-Altman analysis * Weighted kappa coefficient for the classification of patients according to LVEF categories (≤40%, 41-49%, and ≥50%)

Trial sites (1)

FacilityCityRegionStatus
Broca Hospital Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07701369 on ClinicalTrials.gov ↗ ← All trials in France