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Evaluating Cardiac POCUS and AI for Children with Heart Conditions

This observational study is looking at how well a cardiac Point-of-Care Ultrasound (POCUS) performed by emergency medicine (PEM) fellows, and an AI-assisted interpretation using the Exo Iris probe, can detect heart problems in children. Specifically, it's comparing these methods to a full echocardiogram (a detailed heart ultrasound) for finding left ventricular (LV) systolic dysfunction (when the heart's main pumping chamber doesn't squeeze well) and fluid around the heart (pericardial effusion). Children aged 1 month to 21 years with existing heart conditions can join. The study aims to see if these newer methods are as accurate as a full echocardiogram. The study is currently recruiting 200 participants, but its overall status is unclear.

Study design
This is an observational study planning to enroll 200 participants. It compares different diagnostic methods without assigning specific treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, presence of pericardial effusion and LV systolic dysfunction, will be measured at 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07503158

Prospective Evaluation of Cardiac Point-of-Care Ultrasound (POCUS) Performed by PEM Fellows and Artificial Intelligence on Children With Pre-existing Cardiac Conditions.

Not Yet Recruiting
Not specifiedAges 1–21Observational
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
~200 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:AI Pocus_Cardiac

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
presence of pericardial effusion and LV systolic dysfunction
Measured over 2 years

Conditions

Cardiac Anomalies

Explore related trials

Heart Disorder

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Paul Khalil, MD Medical Director Care Ultrasound Program, MD
[email protected]
1-786-624-3742
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Eligibility criteria

Inclusion

Children aged 0-21 years
Preexisting cardiac disease
Participants are either evaluated in the ED or in the cardiology setting.

Exclusion

Participant's clinical condition requires immediate life-saving interventions
New diagnosis of cardiac condition
Preexisting cardiac abnormality documented prior to the index encounter.

What this trial measures

  • presence of pericardial effusion and LV systolic dysfunction2 years

    Diagnostic test characteristics (sensitivity, specificity, predictive values, and the Kappa statistic) for PEM fellow interpretation and AI interpretation will be calculated using complete echocardiography as the reference standard