HF_01: PROSPECTIVE EVALUATION OF HEARTFOCUS

Sponsor

DESKi (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05874128

Collaborator

(none)

240

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Device: Prospective evaluation of HeartFocus Device (Software)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medical Device (Software) ONLY FOR CLINICAL TRIALS	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

Arm

Intervention/Treatment

Experimental: Medical Device (Software)

ONLY FOR CLINICAL TRIALS

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

Outcome Measures

Primary Outcome Measures

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 left ventricular size (yes/no)
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 left ventricular function (yes/no)
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 right ventricle size (yes/no)
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

Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The function of the right ventricle?
Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The size of the inferior vena cava?
Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The size of the left atrium?
Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The aortic valve?
Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The mitral valve?
Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): •The tricuspid valve
Secondary endpoints - Qualitative [Through study completion, an average of 8 months]
The cardiologists will evaluate whether the ultrasound exam performed has sufficient quality to visually analyze (yes/no): • The segmental kinetics?
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): • Left ventricular
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o End-systolic and end-diastolic volumes
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o Left ventricular function.
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o Left ventricular parameters will be assessed by cardiologists
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): • Parasternal analysis
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o Septal wall thickness
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o Posterior wall thickness
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o Internal diameter of the left ventricle (systole and diastole)
Secondary endpoints - Quantitative [Through study completion, an average of 8 months]
The cardiologists will determine on the ultrasound measurements (quantitative): o Aortic diameter
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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