ClearSight System CHN Study

Completed

• Conditions: Patient With Clinically Indicated Invasive Monitoring

• Registration Number: NCT03807622
• Lead Sponsor: Edwards Lifesciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-25
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-17
• Primary Completion: 2019-10-17
• Study Completion: 2019-10-17
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac Output using the Non-invasive ClearSight System	Expected to last no more than 6 hours	Cardiac Output using the Non-invasive ClearSight System

Secondary Outcome Measures

Name	Time	Method
The percentage error (PE) between the ClearSight System CO and TD	Expected to last no more than 6 hours	The percentage error (PE) between the ClearSight System CO and TD

Trial Locations

Locations (3)

Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing; 🇨🇳 Xicheng, Beijing, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei Sheng, China

Tianjin Chest Hospital; 🇨🇳 Heping, Tianjin, China