PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS (HF-01)
Phase: NA
Conditions: Cardiac Disease
Sponsor: DESKi

 
 
PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
 
Protocol title    
PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE 
SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS 
Version Date  
23/12/2023 
NCT 
NCT05874128 
 
 
 
 
 
 
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PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
 
PRIMARY 
HYPOTHESIS 
The primary hypothesis is that novices without previous experience in 
ultrasound examination could obtain diagnostic-quality acquisitions with 
the software HeartFocus.  
 
OBJECTIVES  
The primary objective of the study is to evaluate if ultrasound exams, 
performed with the HeartFocus software by novices, nurses without prior 
ultrasound experience, are of sufficient quality to analyze visually: 
•​
The left ventricular size, 
•​
The left ventricular function, 
•​
The right ventricular size,  
•​
The presence of non-trivial pericardial effusion.  
 
The secondary objectives are: 
•​
To evaluate the agreement between the acquisitions obtained by 
experts and those obtained by novices in terms of quality and 
echocardiographic parameters (secondary endpoints 1 to 4)  
•​
To evaluate the impact of the investigating centers, prior cardiac 
diagnoses, and obese patients on the quality of ultrasound exam  
•​
To evaluate the time to acquire a limited ultrasound exam for a 
novice with the HeartFocus software.   
•​
To evaluate the performance of HeartEF, to automatically 
calculate the ejection fraction   
NUMBER OF 
SUBJECTS  
240 patients will be included, 120 in Site 01 and 120 in Site 2  
 
As part of their training, novices will practice cardiac ultrasound acquisition 
on 72 patients (36 in Site 01 and 36 in Site 2). Those patients will be not 
included in the analysis. They will sign a different consent form. 
STUDY DURATION  
●​ Length of inclusion period: 5 months  
●​ Duration of follow-up per participant / inclusion for the training: 
approximately 30 additional minutes  
●​ Duration of follow-up per participant / inclusion for the analysis: 
approximately 40 additional minutes  
●​ Total research duration: 5 months for inclusion + 5 months for 
outcome analysis. 
STUDY DESIGN  
This prospective multicentric international non inferiority pivotal 
investigation will evaluate the ability of the Heartfocus software in 
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PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
supporting 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. 
 
Novices will be nurses without prior ultrasound experience who have 
received dedicated training on cardiac ultrasound and on Heartfocus 
software. 
 
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 of 10 reference views (Table 1). 
 
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 the Clarius phased array probe and the HeartFocus 
software with the guidance system,  
•​
one by an expert (experienced sonographer/cardiologist) with 
the Clarius phased array probe and the HeartFocus software 
without the guidance system. 
 
A total of 8 novices will perform the acquisition on 30 different patients 
each. In total 240 patients will be included in the analysis, half in each 
investigator center. The exams (240 acquired by novices, 240 by experts) 
will be assessed by a review committee, composed by 5 different 
cardiologists. 
Each exam will be reviewed by all 5 cardiologists from this committee.  
INCLUSION CRITERIA  
•​
Patient (male or female) over 18 years old, 
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PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
•​
Patient having an echocardiography examination scheduled in 
one of the two investigation centers, 
•​
Patient who has given his consent to participate in the research 
and signed consent form, 
•​
Social security affiliation (for France only). 
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 consent, 
•​
Pregnant or breastfeeding women (declarative), 
•​
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 pneumonectomy. 
ENDPOINTS 
All endpoints will be assessed by 5 different cardiologists, from the review 
committee. The criteria will be assessed on the exams obtained by novices 
and those obtained by experts, for each patient. Cardiologists will not know 
if the exam was performed by a novice or an expert.  
 
Primary endpoints:  
The cardiologists will evaluate whether the ultrasound exam performed has 
sufficient quality to visually analyze (binary yes/no) : 
•​
The left ventricular size (yes/no) 
•​
The left ventricular function (yes/no) 
•​
The right ventricle size (yes/no) 
•​
The presence of non-trivial pericardial effusion (yes/no) 
 
Secondary endpoints:  
1- The cardiologists will evaluate whether the ultrasound exam performed 
has sufficient quality to visually analyze (binary yes/no): 
•​
The function of the right ventricle? 
•​
The size of the inferior vena cava? 
•​
The size of the left atrium? 
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PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
•​
The aortic valve? 
•​
The mitral valve? 
•​
The tricuspid valve? 
•​
The segmental kinetics? 
 
2- The cardiologists will evaluate whether the quality of each clip is good 
enough for their interpretation (binary yes/no) (Yes : ACEP>= 3).. 
 
3- The cardiologists will determine on the ultrasound measurements: 
(qualitative yes/no) 
•​
Is there a left ventricular hypertrophy? 
•​
Is there a right ventricular hypertrophy? 
•​
Is there a dilation of the left ventricle? 
•​
Is there a dilation of the right ventricle? 
•​
Is there a dilation of the left atrium?  
•​
Is there a dilation of the right atrium? 
•​
Is there an abnormal left ventricular function? 
•​
Is there an abnormal right ventricular function? 
•​
Is there an abnormal mitral valve? 
•​
Is there an abnormal tricuspid valve? 
•​
Is there an abnormal aortic valve? 
•​
Is there a pericardial effusion? 
•​
Is there a dilatation of the inferior vena cava? 
•​
Is there a kinetic disorder? 
•​
Is there another abnormality? (comments)  
 
4- The cardiologists will determine on the acquisitions the following 
ultrasound measurements (quantitative) 
•​
Left ventricular 
o​ End-systolic and end-diastolic volumes 
o​ Left ventricular function. 
o​ Left ventricular parameters will be assessed by cardiologists 
using the Simpson Biplane method and through the HeartEF 
algorithm developed by DESKi. 
•​
Parasternal analysis 
o​ Septal wall thickness  
o​ Posterior wall thickness  
o​ Internal diameter of the left ventricle (systole and diastole)  
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PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
o​ Aortic diameter  
•​
Diameter of the inferior vena cava 
5- The acquisition time for the limited ultrasound exam 
MEDICAL DEVICES / 
CLINICAL 
INVESTIGATION 
STRATEGIES  
/PROCEDURES  
The HeartFocus software has not yet obtained the FDA or CE certification.  
This clinical trial aims to collect clinical evidence for FDA and CE 
certification.  
The device is classified as Class IIa - software under MDR in Europe and 
Class II in US following FDA classification. 
HeartFocus software is compatible with the ultrasound probe Clarius 
phased array. This probe has received FDA certification and CE certification.  
ANALYSIS  
Patient description: The population will be described in terms of 
demographics, ultrasound parameters, and pathology. 
 
Endpoints: For all quality criteria, the percentage of success and its 
confidence interval will be evaluated for acquisitions performed by experts 
and acquisitions performed by novices. This analysis will be performed via a 
multi-reader, multi-case power analysis. 
 
For each qualitative ultrasound measurement, taking into account the 
experts’ acquisition as the reference, the following parameters will be 
evaluated: 
●​ Percentage of agreement 
●​ Sensitivity 
●​ Specificity 
●​ Precision 
●​ Recall 
●​ F1-score 
●​ Area under the curve 
 
For each quantitative ultrasound measurement: 
●​ The mean, standard deviation and 95% confidence interval of the 
difference will be calculated between the measurements made on 
the acquisitions obtained by the experts and those obtained by the 
novices 
●​ Bland-Altman plots and correlation plots will be performed. 
 
Sensitivity studies will be performed on the investigating centers, prior 
cardiac diagnoses, and obese patients.  
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PROSPECTIVE EVALUATION OF HEARTFOCUS: A 
SOFTWARE SUPPORTING THE ACQUISITION OF 
CARDIAC ULTRASOUND EXAMS 
HF-01 
Version:4.2 
 
 
The evaluation of HeartEF will be performed by comparing the results from 
the algorithm to the manual cardiologist’s analysis.  
 
EXPECTED IMPACTS 
From a medical point of view, there will be no direct benefit for the patient 
included in the analysis. 
At a larger scale, HeartFocus software will outlook access to ultrasound 
exams by allowing non-experts (emergency physicians, residents, general 
practitioners, paramedics, and nurses) to acquire cardiac ultrasound exams 
of sufficient quality for their analysis, without any previous experience in 
echography. 
This would improve patient management by optimizing the care pathway, 
with echography being used as a screening or follow-up tool for patients. 
 
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