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ClearSight System CHN Study

NCT03807622 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2019-11-12

No results posted yet for this study

Summary

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.

Conditions

  • Patient With Clinically Indicated Invasive Monitoring

Interventions

DEVICE

EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-25
Primary Completion
2019-10-17
Completion
2019-10-17
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03807622 on ClinicalTrials.gov