Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) as an Aid in the Diagnosis of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Avicena LLC
- 入组人数
- 406
- 试验地点
- 2
- 主要终点
- The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
研究概览
简要总结
The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during left heart catheterization.
详细描述
Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects >21 years of age.
- •Referred for non-emergent left heart catheterization inclusive of direct measurement of LVDP as part of routine clinical management, to be performed from a femoral or radial access site.
- •Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records.
- •Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.
排除标准
- •Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support.
- •Carotid pulse is not palpable by a trained study researcher.
- •History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck).
- •History of significant or symptomatic carotid artery disease, including TIA, ultrasound evidence of >60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery.
- •Open skin lesions at the site of Vivio application / examination.
- •Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.).
- •Inability to obtain brachial artery blood pressure.
结局指标
主要结局
The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
时间窗: 1 year
The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
次要结局
未报告次要终点