ClearSight System CHN Study

November 8, 2019 updated by: Edwards Lifesciences

A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Xicheng, Beijing, China, 100037
        • Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing
    • Hubei Sheng
      • Wuhan, Hubei Sheng, China, 430072
        • Wuhan Asia Heart Hospital
    • Tianjin
      • Heping, Tianjin, China, 300300
        • Tianjin Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing elective major cardiothoracic surgery with an indwelling PA catheter. The surgical intervention includes, but is not limited to, mitral valve surgery or coronary artery bypass grafting.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Output using the Non-invasive ClearSight System
Time Frame: Expected to last no more than 6 hours
Cardiac Output using the Non-invasive ClearSight System
Expected to last no more than 6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage error (PE) between the ClearSight System CO and TD
Time Frame: Expected to last no more than 6 hours
The percentage error (PE) between the ClearSight System CO and TD
Expected to last no more than 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 25, 2018

Primary Completion (ACTUAL)

October 17, 2019

Study Completion (ACTUAL)

October 17, 2019

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

January 15, 2019

First Posted (ACTUAL)

January 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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