Trials / Completed
CompletedNCT03807622
ClearSight System CHN Study
A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System | EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System |
Timeline
- Start date
- 2018-12-25
- Primary completion
- 2019-10-17
- Completion
- 2019-10-17
- First posted
- 2019-01-17
- Last updated
- 2019-11-12
Locations
3 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03807622. Inclusion in this directory is not an endorsement.