A Multi-Site Observational Clinical Investigation to Collect Non-invasive Sensor Data During a Right Heart Catheterization and Train Machine Learning Models to Estimate Intracardiac Hemodynamic Parameters Evaluation of a Novel maChine leArning Model's Performance for Non-invasive inTracardiac pressURE Monitoring in Heart Failure - The CAPTURE-HF Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,602
- 试验地点
- 18
- 主要终点
- Evaluation of the ML's performance to estimate pressure
研究概览
简要总结
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic assessment. The device will be intended as a companion test or clinical decision support tool to be used and interpreted by qualified healthcare professionals to aid standard-of-care clinical assessment in identifying hemodynamic congestion and supporting personalized treatment of heart failure and pulmonary congestion.
This study is part of the development of a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters. It will be conducted to collect the data needed to train the machine learning models retrospectively.
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
- 是
入选标准
- •Subject is, at least, 18 years of age at the time of screening visit.
- •Subject is willing and physically able to comply with the specified evaluations as per the clinical investigation plan, as assessed by the investigator.
- •Subject is referred for invasive hemodynamic assessment with right heart cardiac catheterization.
- •Patient has provided written informed consent using the Ethics Committee/ Institutional Review Board approved consent form.
排除标准
- •Discretionary exclusion when, in the opinion of the investigator, the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the clinical investigation.
- •Subjects who are pregnant are excluded in the US
结局指标
主要结局
Evaluation of the ML's performance to estimate pressure
时间窗: Day 0 to Day 90
Performance of the ML model trained on data collected from the ASDC System to estimate left-sided filling pressure compared to right heart catheterization.
次要结局
- Diagnostic accuracy of ML model(Day 0 to Day 90)
- Evaluation of the ML's performance to estimate other hemodynamic parameters(Day 0 to Day 90)