Clinical trial NCT05874128: PROSPECTIVE EVALUATION OF HEARTFOCUS
Official title: PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Cardiac disease
Novices
Guidance
Artificial intelligence
Ejection Fraction
Ultrasound
Lead sponsor: DESKi
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary endpoints
timeFrame: Through study completion, an average of 8 months
measure: Primary endpoints
timeFrame: Through study completion, an average of 8 months
measure: Primary endpoints
timeFrame: Through study completion, an average of 8 months
measure: Primary endpoints
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Qualitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Quantitative
timeFrame: Through study completion, an average of 8 months
measure: Secondary endpoints - Diagnotics
timeFrame: Through study completion, an average of 8 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
state: Aquitaine
Study officials:
affiliation: Department of Cardiology Lenox Hill Hospital
name: Biana Trost, MD, FACC, FASE
role: PRINCIPAL_INVESTIGATOR
References: