NCT07205341招募中不适用
A Pilot Clinical Study to Assess Correlation Between Arterial Blood Volume Status and Cardiac Efficiency, and HemoCept Device Data in Trans-Aortic Valve Replacement (TAVR} Surgery
HemoCept Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月29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
- 20
- 试验地点
- 1
- 主要终点
- Correlation of HemoCept device measurements with aortic valve pressure gradient changes.
研究概览
简要总结
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
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 80 Years（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 between (and including) the ages of 18 and
- •Subject ls being treated by the participating healthcare facility .
- •., Subject requires a trans-aortic valve replacement.
- •Subject is able and willing to provide informed consent and HIPM authorization.
- •Subject is able and willing to meet all study requirements.
排除标准
- •Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- •Subject has a personal medical history that includes:
- •Long O-T syndrome
- •Cardiac channelopathies
结局指标
主要结局
Correlation of HemoCept device measurements with aortic valve pressure gradient changes.
时间窗: Perioperative; immediately before procedure, and up to 24 hours after the procedure
The primary endpoint is the ability of the HemoCept device to properly detect changes consistent with aortic valve pressure gradient values, measured by echocardiogram pre and post TAVR procedure.
次要结局
未报告次要终点
研究者
研究点 (1)
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