NCT07224906招募中不适用
Observational Study of the HemoCept Device During Right Heart Catheterization at Boulder Heart
HemoCept Inc.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Association between device measurements and Pulmonary Capillary Wedge Pressure
研究概览
简要总结
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.
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
- •Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
- •Subjects can be any gender but must be age 18 or older.
- •Subject is able and willing to provide informed consent and HIPAA authorization.
- •Subject is able and willing to meet all study requirements.
- •Scheduled for a diagnostic right heart catheterization (RHC-only or combined RHC+LHC; left-heart-only procedures are not eligible)
排除标准
- •Subject is pregnant, breastfeeding, or intends to become pregnant during this study.
结局指标
主要结局
Association between device measurements and Pulmonary Capillary Wedge Pressure
时间窗: Day 1
The correlation of HemoCept device measurements to Pulmonary Capillary Wedge Pressure (PCWP) measured during right heart catheterization.
次要结局
未报告次要终点
研究者
研究点 (2)
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