PROSPECTIVE EVALUATION OF HEARTFOCUS

NCT05874128 | Completed Results FDA Device

• 1 other identifier: HF-01
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

Cardiac disease; Novices; Guidance; Artificial intelligence; Ejection Fraction; Ultrasound

Outcome Measures

Primary Outcomes (4)

• The Left Ventricular Size (Qualitative Visual Assessment)

  For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the exam had sufficient image quality to allow visual analysis of left ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.

  Images evaluated by the cardiologists after the acquisition

• The Left Ventricular Function (Qualitative Visual Assessment)

  For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of left ventricular function. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.

  Images evaluated by the cardiologists after the acquisition

• The Right Ventricle Size (Qualitative Visual Assessment)

  For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.

  Images evaluated by the cardiologists after the acquisition

• The Presence of Non-trivial Pericardial Effusion (Qualitative Visual Assessment)

  For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound exam had sufficient image quality to visually analyze the presence of non-trivial pericardial effusion. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.

  Images evaluated by the cardiologists after the acquisition

Secondary Outcomes (18)

• The Function of the Right Ventricle (Qualitative Visual Assessment)

  Images evaluated by the cardiologists after the acquisition

• The Left Atrium Size (Qualitative Visual Assessment)

  Images evaluated by the cardiologists after the acquisition

• The Right Atrium Size (Qualitative Visual Assessment)

  Images evaluated by the cardiologists after the acquisition

• The Segmental Kinetics of the Left Ventricle (Qualitative Visual Assessment)

  Images evaluated by the cardiologists after the acquisition

• The Aortic Valve (Qualitative Visual Assessment)

  Images evaluated by the cardiologists after the acquisition

Study Arms (1)

Study participants

EXPERIMENTAL

240 patients will be included, 120 in Site 01 (Bordeaux) and 120 in Site 02 (New York)

Device: Using HeartFocus software with AI guidance (Novices); Device: Using HeartFocus software without AI-guidance

Interventions

Using HeartFocus software with AI guidance (Novices) DEVICE

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.

Study participants

Using HeartFocus software without AI-guidance DEVICE

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.

Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (male or female) over 18 years old, Patient having an echocardiography examination scheduled in one of the two investigation centers.
• Patient who has given his non-objection to participate in the research

You may not qualify if:

• Patient subject to a measure of legal protection (safeguard of justice, guardianship or curatorship), Patient deprived of liberty by judicial or administrative decision, Patient being unable to give his non-objection, Pregnant or breastfeeding women, Patient with cardiac anatomy that does not allow reference electrocardiographic sections to be made (situs inversus, single ventricle, congenital anomalies, etc), Patient having benefited from prior echocardiographic exams whose reports mention poor or weak echogenicity, Patient having known chest deformity that has already been mentioned in previous reports or has been the subject of investigations (pectum excavatum), Patient who has undergone total or partial pneumectomy

Sponsors & Collaborators

• DESKi: lead

Study Sites (2)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

University Hospital of Bordeaux

Bordeaux, Aquitaine, 33000, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: DESKi

laetitia.rodrigues@deski.ai

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Study Officials

• Biana Trost, MD, FACC, FASE

  Department of Cardiology Lenox Hill Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 24, 2023
• Study Start: November 13, 2023
• Primary Completion: August 16, 2024
• Study Completion: August 16, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1)