Status:
COMPLETED
ClearSight System CHN Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Patient With Clinically Indicated Invasive Monitoring
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 17 2019
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT03807622
Start Date
December 25 2018
End Date
October 17 2019
Last Update
November 12 2019
Active Locations (3)
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1
Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing
Xicheng, Beijing Municipality, China, 100037
2
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430072
3
Tianjin Chest Hospital
Xiaobailou, Tianjin Municipality, China, 300300