NCT Number: NCT05874128
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University Hospital of Bordeaux, Bordeaux, Aquitaine, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
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.
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.
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.
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.
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.
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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
DESKi
Industry
PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS (HF-01)
Acronym: HF-01
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