Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Novice Image Quality
研究概览
简要总结
The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate for relationships between the ultrasound data and pulmonary pressure data from the Abbott CardioMEMS system.
详细描述
Feasibility study to compare an investigational Artificial Intelligence (AI) Auto B-line tool measurement on Lung Ultrasound (US) images acquired with an AI assisted guidance tool by novice ultrasound clinicians and heart failure (HF) patients, to standard of care heart failure monitoring of pulmonary artery pressure measured by the Abbott CardioMEMS system.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Documented diagnosis of heart failure at least three months prior to the date of consent
- •HF currently managed with the Abbott CardioMEMS device
- •Able to read and write in English.
- •At least 18 years of age or older on the date of consent.
- •Willing and able to provide written consent to participation
- •Expressed willingness to capture AI assisted US recordings immediately before or after taking their CardioMEMS measurements
- •Access to WiFi or cellular data connection at home
- •In the opinion of the investigator or delegate the subject, must be capable of complying with study procedures.
排除标准
- •Previous experience using an ultrasound device on themselves or others
- •Women who are pregnant or plan to become pregnant during the study
结局指标
主要结局
Novice Image Quality
时间窗: Study Completion (91 days)
Image quality comparisons between ultrasound scans performed by novice clinicians using the study app to traditional ultrasound scans performed by trained clinicians
Patients Image Quality
时间窗: Study Completion (91 days)
Image quality comparisons between ultrasound scans performed by heart failure patients using the study app to traditional ultrasound scans performed by trained clinicians
B-Line count CardioMEMS comparison
时间窗: Study Completion (91 days)
Relationship comparisons between ultrasound data from exams performed by heart failure patients using the study app (both in clinic and at home) and ultrasound exams performed by novice clinicians to pulmonary pressure data from the Abbott CardioMEMS system
次要结局
- Ease of use(Study Completion (91 days))