PROSPECTIVE EVALUATION OF HEARTFOCUS

Not Applicable

Completed

• Conditions: Cardiac Disease
• Interventions: Device: Prospective evaluation of HeartFocus Device (Software)

• Registration Number: NCT05874128
• Lead Sponsor: DESKi

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.

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-16
• Study First Posted: 2023-05-24
• Study Start: 2023-09-01
• Primary Completion: 2024-04-01
• Status Verified: 2024-08
• Study Completion: 2024-08-16
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medical Device (Software)	Prospective evaluation of HeartFocus Device (Software)	ONLY FOR CLINICAL TRIALS

Primary Outcome Measures

Name	Time	Method
Primary endpoints	Through study completion, an average of 8 months	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (qualitative yes/no): • The presence of non-trivial pericardial effusion (yes/no)

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints - Qualitative	Through study completion, an average of 8 months	2- The cardiologists will evaluate whether the quality of each clip is good enough for their interpretation (qualitative yes/no)?
Secondary endpoints - Quantitative	Through study completion, an average of 8 months	The cardiologists will determine on the ultrasound measurements (quantitative): • Diameter of the inferior vena cava
Secondary endpoints - Diagnotics	Through study completion, an average of 8 months	The cardiologists will determine on the ultrasound exam, is there : (yes/no); * a left ventricular hypertrophy?; * a right ventricular hypertrophy?; * a dilation of the left ventricle?; * a dilation of the right ventricle?; * a dilation of the left atrium?; * a dilation of the right atrium?; * an abnormal left ventricular function?; * an abnormal right ventricular function?; * an abnormal mitral valve?; * an abnormal tricuspid valve?; * an abnormal aortic valve?; * a pericardial effusion?; * a dilatation of the inferior vena cava?; * a kinetic disorder?; * another abnormality? (comments)

Trial Locations

Locations (2)

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

University Hospital of Bordeaux; 🇫🇷 Bordeaux, Aquitaine, France