Skip to main content
OpenTrials
Completed

NCT Number: NCT03807622

ClearSight System CHN Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patient With Clinically Indicated Invasive Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing, Xicheng, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Device

EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.