PROSPECTIVE EVALUATION OF HEARTFOCUS

Cardiac Disease Clinical Trial

— HF_01  

Official title:

PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05874128
• Other study ID #: HF_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: DESKi
• Contact: Bertrand Moal, MD,PhD
• Phone: +33663760854
• Email: bertrand.moal[@]deski.io
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• Prospective evaluation of HeartFocus Device (Software)
The primary objective of the study is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to analyze visually

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DESKi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoints	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (qualitative yes/no): • The left ventricular size (yes/no)	Through study completion, an average of 8 months
Primary	Primary endpoints	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (qualitative yes/no): • The left ventricular function (yes/no)	Through study completion, an average of 8 months
Primary	Primary endpoints	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (qualitative yes/no): • The right ventricle size (yes/no)	Through study completion, an average of 8 months
Primary	Primary endpoints	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)	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The function of the right ventricle?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The size of the inferior vena cava?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The size of the left atrium?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The aortic valve?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The mitral valve?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): •The tricuspid valve	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The segmental kinetics?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Qualitative	2- The cardiologists will evaluate whether the quality of each clip is good enough for their interpretation (qualitative yes/no)?	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): • Left ventricular	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o End-systolic and end-diastolic volumes	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o Left ventricular function.	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o Left ventricular parameters will be assessed by cardiologists	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): • Parasternal analysis	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o Septal wall thickness	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o Posterior wall thickness	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o Internal diameter of the left ventricle (systole and diastole)	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): o Aortic diameter	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Quantitative	The cardiologists will determine on the ultrasound measurements (quantitative): • Diameter of the inferior vena cava	Through study completion, an average of 8 months
Secondary	Secondary endpoints - Diagnotics	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)	Through study completion, an average of 8 months