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临床试验/NCT03430102
NCT03430102已完成不适用

Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP

Vixiar Medical, Inc.4 个研究点 分布在 1 个国家目标入组 289 人开始时间: 2018年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
289
试验地点
4
主要终点
C-LVEDP

研究概览

简要总结

The study is designed to repeat an initial training set study conducted at Johns Hopkins Medical Center, comparing a new investigational device, Indicor, a non-invasive tool for estimating left ventricular end diastolic pressure (LVEDP), to the gold standard, invasively measured LVEDP via direct measurement via left heart catheterization. The study is divided into an initial training set, followed by the validation set which is designed to support an FDA 510(k) submission and validate the final algorithm. Patients will be enrolled who are scheduled to undergo a cardiac catheterization and will be asked to perform three tests with the Indicor.

详细描述

Patients who are scheduled to undergo a left heart cardiac catheterization for direct measure of left ventricular end diastolic pressure (LVEDP) as part of routine care will be asked to participate. Investigators will take non-invasive measures of LVEDP using the Indicor device, repeated at three time points before and after the catheterization procedure. The Indicor indirectly measures LVEDP by calculating a value from finger photoplethysmography (PPG) waveforms that will be recorded while the patient performs a Valsalva maneuver.

Participants baseline characteristics will be gathered from the electronic medical record, including history of coronary artery disease, heart failure, hypertension, diabetes, or lung disease; list of blood pressure medications; serum markers of kidney function; and echocardiogram measurements including ejection fraction. These parameters will be used to assess relevance to the calculation of LVEDP by Indicor.

The first Indicor measure will be conducted before the catheterization procedure. PPG probes will be attached to participants' first or second finger. Participants will be asked to strain as if having a bowel movement (Valsalva maneuver) for 10 seconds. Participants will blow into a pressure transducer that measures and displays the pressure of their effort. The Indicor device will acquire 3 successful efforts.

During the cardiac catheterization, while the pressure transducer used by the clinical team to measure LVEDP is in the aorta, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts. This will allow investigators to determine how well the amplitude changes of the PPG signal during Valsalva maneuver reflect the amplitude changes of central arterial pressure during the Valsalva maneuver. According to experienced catheterization cardiologists, this set of tests will not add significant risk to the procedure. This second set of tests may not be performed in all participants.

Immediately after the cardiac catheterization, while the patient is still on the catheterization table, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts.

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

  • •Adult patients scheduled to undergo a left-heart catheterization that will include the measurement of left ventricular end-diastolic pressure (LVEDP)

排除标准

  • •Weight <88 pounds (40 kilograms)
  • •Atrial flutter or atrial fibrillation with an irregular ventricular response
  • •Significant atrial or ventricular ectopy
  • •History of paradoxical emboli
  • •Hypertrophic obstructive cardiomyopathy
  • •History of paradoxical emboli
  • •Known intracardiac shunt
  • •Known severe aortic valve stenosis or known severe mitral valve stenosis
  • •History of embolic cerebrovascular accident
  • •Clinically unstable
  • •Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP> 100 mmHg)
  • •Hypotension (systolic BP <90 mmHg)
  • •Symptomatic bradycardia
  • •Known cholesterol emboli
  • •Poor LV function with known LV thrombus

结局指标

主要结局

C-LVEDP

时间窗: During patients scheduled left heart cardiac catheterization

Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) \> 20 mmHg

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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