A Multi-site, Prospective, Non-interventional, Observational Data Collection Study in Patients Undergoing a Right Heart Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 392
- 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
- 否
入选标准
- •Subject is at least 18 years of age at the time of screening.
- •Subject is willing and physically able to comply with the specified evaluations as per the protocol.
- •Subject is referred for invasive hemodynamic assessment with right heart catheterization.
- •Subject has provided written informed consent using the approved consent form.
排除标准
- •Discretionary exclusion when the inclusion of a potential subject is not in their best interest or not in the interest of compliant performance of the study.
研究组 & 干预措施
RHC
Patients enrolled for a right heart catheterization procedure as part of their standard of care.
干预措施: Data collection (Device)
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 Machine Learning model trained on data collected from the device to estimate left-sided filling pressure compared to right heart catheterization.
次要结局
未报告次要终点