MedTrace Logo

PROSPECTIVE EVALUATION OF HEARTFOCUS

NCT05874128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-01-29

Study results available
· View outcomes & findings →

Summary

The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion.

Novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on Heartfocus software. Ultrasound exams will be limited to the acquisition of 10 reference views

Conditions

  • Cardiac Disease

Interventions

DEVICE

Using HeartFocus software with AI guidance (Novices)

The novice are nurses without prior ultrasound experience performed limited echocardiograms using the HeartFocus AI-based guidance software (DESKi). After a half-day training and practice on ≤9 patients, each novice acquired echocardiographic clips for 10 standard transthoracic views with the assistance of real-time software guidance and automated recording.

DEVICE

Using HeartFocus software without AI-guidance

Experienced sonographers and cardiologists performed limited echocardiograms using HeartFocus software, without AI assistance. The experts acquired echocardiographic sequences corresponding to the 10 standard transthoracic views, just like the novices.

Sponsors & Collaborators

  • DESKi

    lead INDUSTRY

Principal Investigators

  • Biana Trost, MD, FACC, FASE · Department of Cardiology Lenox Hill Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2024-08-16
Completion
2024-08-16
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874128 on ClinicalTrials.gov