PROSPECTIVE EVALUATION OF HEARTFOCUS: A SOFTWARE SUPPORTING THE ACQUISITION OF CARDIAC ULTRASOUND EXAMS (HF-01)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- The Left Ventricular Size (Qualitative Visual Assessment)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study participants
240 patients will be included, 120 in Site 01 (Bordeaux) and 120 in Site 02 (New York)
干预措施: Using HeartFocus software with AI guidance (Novices) (Device)
Study participants
240 patients will be included, 120 in Site 01 (Bordeaux) and 120 in Site 02 (New York)
干预措施: Using HeartFocus software without AI-guidance (Device)
结局指标
主要结局
The Left Ventricular Size (Qualitative Visual Assessment)
时间窗: Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the exam had sufficient image quality to allow visual analysis of left ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.
The Left Ventricular Function (Qualitative Visual Assessment)
时间窗: Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of left ventricular function. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.
The Right Ventricle Size (Qualitative Visual Assessment)
时间窗: Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.
The Presence of Non-trivial Pericardial Effusion (Qualitative Visual Assessment)
时间窗: Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound exam had sufficient image quality to visually analyze the presence of non-trivial pericardial effusion. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality.
次要结局
- The Function of the Right Ventricle (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Left Atrium Size (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Right Atrium Size (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Segmental Kinetics of the Left Ventricle (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Aortic Valve (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Mitral Valve (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Tricuspid Valve (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- The Size of Inferior Vena Cava (Qualitative Visual Assessment)(Images evaluated by the cardiologists after the acquisition)
- Apical-2-Chamber (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Apical-3-Chamber (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Apical-4-Chamber (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Apical-5-Chamber (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Parasternal Long Axis (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Parasternal Short Axis Aortic (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Parasternal Short Axis Mitral (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Parasternal Short Axis Papillary Muscles (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Sub Costal-4-Chamber (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)
- Sub Costal Inferior Vena Cava (Diagnostic Quality Clip)(Images evaluated by the cardiologists after the acquisition)