Evaluation of Limited Trans Thoracic Echocardiography (L-TTE) by Non-Sonographers Using the UltraSight AI Guidance Software in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients Eligible for Mavacamten (Camzyos™) Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Agreement in Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
This study evaluates whether healthcare providers without specialized ultrasound training can use UltraSight's machine learning based Guidance Software to perform limited transthoracic echocardiography in patients with hypertrophic obstructive cardiomyopathy (HOCM), who are receiving or eligible for mavacamten (Camzyos™). Participants will undergo two heart scans on the same day, one by a non-sonographer using the software and one by a trained sonographer. The study aims to determine if the software-guided images are comparable in quality, with the goal of expanding access to heart monitoring for HCM patients.
详细描述
This study is evaluating whether healthcare providers without specialized ultrasound training can use UltraSight's Guidance Software to perform heart ultrasound exams (limited transthoracic echocardiography) in patients with hypertrophic obstructive cardiomyopathy (HOCM) who are receiving or eligible for treatment with Camzyos™ (mavacamten). The study aims to determine if the software-guided images are comparable to those taken by the sonographers, in quality. Participants will receive two echocardiography scans on the same day (one by a non-sonographer using UltraSight's Guidance Software and one by a sonographer), and the image quality will be reviewed by expert cardiologists. The study aims to increase patients' access to cardiac monitoring, especially for this patient population, by enabling more healthcare professionals to perform these echocardiography exams safely and effectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 18 years or over at the time of screening.
- •Willing and able to give written informed consent.
- •New York Heart Association (NYHA) Class I to III
- •Eligible to receive or currently receiving CamzyosTM per product labelling.
排除标准
- •Emergency (non-elective) admission within 24 hours prior to participating in the study.
- •Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
- •Subjects who had technically difficult exam in the past, due to body habitus, upon investigator's discretion.
- •Subjects with body mass index (BMI) above 40 kg/m
- •Subjects experiencing a known or suspected acute cardiac event.
- •Subjects with severe chest wall deformities as per previous medical records and physical examination.
- •Subjects who have undergone pneumonectomy.
- •Subjects whose anatomy does not lend itself to yield diagnosable echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, etc.).
研究组 & 干预措施
Hypertrophic obstructive cardiomyopathy (HOCM) Patients Undergoing two Echo Exams
Hypertrophic obstructive cardiomyopathy (HOCM) patients who are eligible for or currently receiving Camzyos™ (mavacamten) will undergo two limited transthoracic echocardiography (LTTE) exams on the same day: one performed by a trained sonographer, and the other by a non-sonographer healthcare provider using the UltraSight Guidance Software. The study will compare the image quality and diagnostic agreement between the two sets of scans to evaluate the software's ability to support non-experts in performing cardiac ultrasound.
结局指标
主要结局
Agreement in Left Ventricular Ejection Fraction (LVEF)
时间窗: 1 day
To demonstrate agreement in echocardiography data between limited transthoracic echocardiography (LTTE) exams performed by non-sonographer healthcare professionals (HCPs) using the UltraSight Software and exams performed by trained sonographers. LVEF will be assessed using Simpson's Method and categorized into predefined groups. The expert cardiologists evaluating the LVEF will be blinded to the exam performer's identity.
次要结局
- Agreement in Quality level of Specific Echocardiographic Views Between Non-Sonographer HCPs and Sonographers, using ACEP echocardiography images' quality scale(1 day)
- Number of participants with adverse events (AEs) as assessed by CTCAE v4.0(1 day)