ClearSight System CHN Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03807622

Enrollment

125

Registered

2019-01-17

Start date

2018-12-25

Completion date

2019-10-17

Last updated

2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient With Clinically Indicated Invasive Monitoring

Keywords

Elective Major Cardiothoracic, Mitral Valve Surgery, Coronary Artery Bypass Grafting

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.

Interventions

DEVICEEV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026