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ClearSight System CHN Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807622
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Patient With Clinically Indicated Invasive Monitoring Device: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Study Design
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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China
Actual Study Start Date : December 25, 2018
Actual Primary Completion Date : October 17, 2019
Actual Study Completion Date : October 17, 2019
Groups and Cohorts
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Intervention Details:
  • Device: EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
    EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807622


Locations
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China, Beijing
Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing
Xicheng, Beijing, China, 100037
China, Hubei Sheng
Wuhan Asia Heart Hospital
Wuhan, Hubei Sheng, China, 430072
China, Tianjin
Tianjin Chest Hospital
Heping, Tianjin, China, 300300
Sponsors and Collaborators
Edwards Lifesciences
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03807622    
Other Study ID Numbers: 2018-05
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Edwards Lifesciences:
Elective Major Cardiothoracic
Mitral Valve Surgery
Coronary Artery Bypass Grafting