ClearSight System CHN Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-25

Study Completion Date

2019-10-17

Brief Summary

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The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The results of this study may be used for registration and regulatory submissions.

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Detailed Description

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Conditions

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Patient With Clinically Indicated Invasive Monitoring

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects must be at least 18 years of age
* Subjects provide written informed consent prior to trial procedures
* Subjects' height and weight must be accurately obtained prior to study start.

Exclusion Criteria

* Aortic or tricuspid valve regurgitation
* Aortic stenosis or aneurysms
* Cardiac rhythm disorder
* Patients with extreme contraction of the smooth muscle in the arteries and arterioles in the lower arm and hand, such as may be present in patients with Raynaud's or Buerger's disease or with extremely cold hands
* Inability to place the finger cuff appropriately due to subject anatomy or condition
* Known pregnancy
* Patients being treated with an intra-aortic balloon pump
* Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
* Intracardiac shunt

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No