NCT07148323招募中不适用
HemoSphere Alta Clinical Development Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
研究概览
简要总结
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
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
- •Signed informed consent
- •Age ≥ 18 years
- •Planned monitoring with a pulmonary artery catheter
- •Patient scheduled to undergo cardiac or liver transplant surgery lasting > 2 hours
- •Additional criteria for Sub-Cohort A (RVF)
- •Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE)
- •Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure
- •Additional criteria for Sub-Cohort B (CAI)
- •Age ≥ 45 years
- •Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
- •Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period
- •High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure > 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease
排除标准
- •Inability to provide informed consent
- •Pregnancy as confirmed per EMR
- •Patients deemed not suitable for the study at the discretion of the Investigator
- •Participation in another study that clinically interferes with the current study
- •Additional exclusion criteria for Sub-Cohort A
- •Presence of left bundle branch block
- •Presence of current/recurrent sepsis
- •Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation
- •Structural abnormality, including congenital heart defects, of the right ventricle
- •Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect
结局指标
主要结局
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
时间窗: Up to 72 hours of device data collection during surgery and ICU
Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development.
次要结局
未报告次要终点
研究者
研究点 (1)
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