Cardiac DiseaseHF-01NCT05874128
PROSPECTIVE EVALUATION OF HEARTFOCUS
A study testing Using HeartFocus software with AI guidance (Novices) and Using HeartFocus software without AI-guidance in people with Cardiac Disease, run by DESKi at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Using HeartFocus software with AI guidance (Novices) and Using HeartFocus software without AI-guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Nov 2023to 16 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS (HF-01)
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
Read the detailed description
This prospective multicentric international pivotal trial will evaluate the ability of the Heartfocus software to support novices for the acquisition of 10 reference views of cardiac ultrasound. The 10 reference views are the following:
Parasternal long axis, Parasternal short axis at the aortic valve, Parasternal short axis at the mitral valve Parasternal short axis at the papillary muscles Apical 5-chamber, Apical 4-chamber, Apical 3-chamber, Apical 2-chamber, Subcostal 4-chamber, Subcostal inferior vena cava.
Patients included in the study will be adult patients scheduled for an echocardiogram at one of the two investigating centers. Ultrasound exams will be limited to the acquisition 10 reference views.
Patients will receive 2 additional limited exams, which consist of the acquisition of ultrasound clips for each of the 10 references views:
one by a novice, nurses having received a dedicated training of 2 days, with an ultrasound probe and the HeartFocus software with the guidance system, one by an expert (experienced sonographer/cardiologist) with the same ultrasound probe and the HeartFocus software without the guidance system.
A total of 8 novices will perform the acquisition on 30 patients each. In total 240 patients will be included in the study, half in each investigator center. The exams (240 acquired by novices, 240 by experts) will be analyzed by cardiologists to assess their quality. The endpoints are described below.
- Conditions
- Cardiac Disease
- Being tested
- Using HeartFocus software with AI guidance (Novices), Using HeartFocus software without AI-guidance
- Keywords
- Cardiac disease, Novices, Guidance, Artificial intelligence, Ejection Fraction, Ultrasound
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Using HeartFocus software without AI-guidanceDevice
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 group | Role | What they receive |
|---|---|---|
| Study participants | Experimental | 240 patients will be included, 120 in Site 01 (Bordeaux) and 120 in Site 02 (New York) Receives: Device: Using HeartFocus software with AI guidance (Novices); Device: Using HeartFocus software without AI-guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Images evaluated by the cardiologists after the acquisition
Secondary outcomes (18)
The Function of the Right Ventricle (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 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Left Atrium 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 left atrium 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Right Atrium 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 atrium 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Segmental Kinetics of the Left Ventricle (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 the segmental kinetics of the left ventricle. 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Aortic Valve (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 the aortic valve. 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Mitral Valve (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 the mitral valve. 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Tricuspid Valve (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 the tricuspid valve. 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.
Measured: Images evaluated by the cardiologists after the acquisition
The Size of Inferior Vena Cava (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 the size of the inferior vena cava. 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.
Measured: Images evaluated by the cardiologists after the acquisition
Apical-2-Chamber (Diagnostic Quality Clip)
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 Apical-2-Chamber (A2C) clip had sufficient image quality for interpretation, in order to determine the entire endocardial contour of the left ventricle, calculate ejection fraction by Simpson's method, and detect wall motion abnormalities. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Apical-3-Chamber (Diagnostic Quality Clip)
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 Apical-3-Chamber (A3C) clip had sufficient image quality for interpretation, in order to determine the endocardial definition of the left ventricle, detect wall motion abnormalities, and ensure that the right ventricle and aortic valve leaflets were correctly visualized. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Apical-4-Chamber (Diagnostic Quality Clip)
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 Apical-4-Chamber (A4C) clip had sufficient image quality for interpretation, in order to determine the entire endocardial contour of the left ventricle, calculate ejection fraction by Simpson's method, and detect wall motion abnormalities. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Apical-5-Chamber (Diagnostic Quality Clip)
"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 Apical-5-Chamber (A5C) clip had sufficient image quality for interpretation, in order to determine the endocardial definition of the left ventricle and ensure proper visualization of the outflow chamber and aortic valve. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Parasternal Long Axis (Diagnostic Quality Clip)
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 Parasternal Long-Axis (PLAX) clip had sufficient image quality for interpretation, in order to ensure that the basal segments of the left ventricle were visible with adequate image quality for diameter measurement and detection of wall motion abnormalities, and to confirm that the long axis, aortic valve, and right ventricle were correctly visualized to consider the view as a good PLAX. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Parasternal Short Axis Aortic (Diagnostic Quality Clip)
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 Parasternal Short-Axis Aortic (PSAX-AV) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to visualize the aortic valve leaflets. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Parasternal Short Axis Mitral (Diagnostic Quality Clip)
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 Parasternal Short-Axis Mitral (PSAX-MV) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to detect wall motion abnormalities and visualize valvular movement. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Parasternal Short Axis Papillary Muscles (Diagnostic Quality Clip)
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 Parasternal Short-Axis Papillary Muscles (PSAX-PM) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to detect wall motion abnormalities, visualize valvular movement, and visualize both papillary muscles. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Sub Costal-4-Chamber (Diagnostic Quality Clip)
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 Subcostal 4-Chamber (SC-4C) clip had sufficient image quality for interpretation, in order to ensure adequate image quality for detecting a pericardial effusion between the right ventricle and liver. Full visualization of the left and right ventricles was not required. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Sub Costal Inferior Vena Cava (Diagnostic Quality Clip)
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 Subcostal Inferior Vena Cava (SC-IVC) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to measure the diameter of the IVC a few centimeters before it reaches the heart. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained.
Measured: Images evaluated by the cardiologists after the acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start13 Nov 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- DESKi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Biana Trost, MD, FACC, FASE, Principal investigator, Department of Cardiology Lenox Hill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874128
- Sponsor's protocol ID
- HF-01
- Acronym
- HF-01
- Status last verified
- Jan 2026
- First submitted
- 5 May 2023
- Last updated
- 29 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS (HF-01)
- ClinicalTrials.gov ID
- NCT05874128
- Acronym / sponsor ID
- HF-01 / HF-01
- Conditions
- Cardiac Disease
- Keywords
- Cardiac disease, Novices, Guidance, Artificial intelligence, Ejection Fraction, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- DESKiIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Posted 29 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This prospective multicentric international pivotal trial will evaluate the ability of the Heartfocus software to support novices for the acquisition of 10 reference views of cardiac ultrasound. The 10 reference views are the following:
Parasternal long axis, Parasternal short axis at the aortic valve, Parasternal short axis at the mitral valve Parasternal short axis at the papillary muscles Apical 5-chamber, Apical 4-chamber, Apical 3-chamber, Apical 2-chamber, Subcostal 4-chamber, Subcostal inferior vena cava.
Patients included in the study will be adult patients scheduled for an echocardiogram at one of the two investigating centers. Ultrasound exams will be limited to the acquisition 10 reference views.
Patients will receive 2 additional limited exams, which consist of the acquisition of ultrasound clips for each of the 10 references views:
one by a novice, nurses having received a dedicated training of 2 days, with an ultrasound probe and the HeartFocus software with the guidance system, one by an expert (experienced sonographer/cardiologist) with the same ultrasound probe and the HeartFocus software without the guidance system.
A total of 8 novices will perform the acquisition on 30 patients each. In total 240 patients will be included in the study, half in each investigator center. The exams (240 acquired by novices, 240 by experts) will be analyzed by cardiologists to assess their quality. The endpoints are described below.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study participants | Experimental | Device: Using HeartFocus software with AI guidance (Novices), Device: Using HeartFocus software without AI-guidance240 patients will be included, 120 in Site 01 (Bordeaux) and 120 in Site 02 (New York) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Study participants |
| Using HeartFocus software without AI-guidanceExperienced 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. | Device | Study participants |
Primary outcome
The Left Ventricular Size (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
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.
The Left Ventricular Function (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
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.
The Right Ventricle Size (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
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.
The Presence of Non-trivial Pericardial Effusion (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
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.
18 secondary outcomes
The Function of the Right Ventricle (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Left Atrium Size (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Right Atrium Size (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Segmental Kinetics of the Left Ventricle (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Aortic Valve (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Mitral Valve (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Tricuspid Valve (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
The Size of Inferior Vena Cava (Qualitative Visual Assessment)
Time frame: Images evaluated by the cardiologists after the acquisition
Apical-2-Chamber (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Apical-3-Chamber (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Apical-4-Chamber (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Apical-5-Chamber (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Parasternal Long Axis (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Parasternal Short Axis Aortic (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Parasternal Short Axis Mitral (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Parasternal Short Axis Papillary Muscles (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Sub Costal-4-Chamber (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Sub Costal Inferior Vena Cava (Diagnostic Quality Clip)
Time frame: Images evaluated by the cardiologists after the acquisition
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Biana Trost, MD, FACC, FASE principal investigator
Department of Cardiology Lenox Hill Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using HeartFocus software with AI guidance (Novices) and Using HeartFocus software without AI-guidance in people with Cardiac Disease, run by DESKi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Left Ventricular Size (Qualitative Visual Assessment) (time frame: Images evaluated by the cardiologists after the acquisition). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.