ClearSight System CHN Study

Patient With Clinically Indicated Invasive Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807622
• Other study ID #: 2018-05
• Status: Completed
• Start date: December 25, 2018
• Est. completion date: October 17, 2019

Study information

• Verified date: November 2019
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 17, 2019
• Est. primary completion date: October 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patient With Clinically Indicated Invasive Monitoring

Intervention

Device:
• EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Locations

Country	Name	City	State
China	Tianjin Chest Hospital	Heping	Tianjin
China	Wuhan Asia Heart Hospital	Wuhan	Hubei Sheng
China	Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing	Xicheng	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output using the Non-invasive ClearSight System	Cardiac Output using the Non-invasive ClearSight System	Expected to last no more than 6 hours
Secondary	The percentage error (PE) between the ClearSight System CO and TD	The percentage error (PE) between the ClearSight System CO and TD	Expected to last no more than 6 hours