Patient With Clinically Indicated Invasive MonitoringNCT03807622
ClearSight System CHN Study
An observational study of Patient With Clinically Indicated Invasive Monitoring, run by Edwards Lifesciences at 3 sites in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient With Clinically Indicated Invasive Monitoring
- What is being tested?
- EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 3 sitesChina
- Study dates
- 25 Dec 2018to 17 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective major cardiothoracic surgery with an indwelling PA catheter. The surgical intervention includes, but is not limited to, mitral valve surgery or coronary artery bypass grafting.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430072
Tianjin Chest Hospital
Xiaobailou, Tianjin Municipality, 300300
Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing
Xicheng, Beijing Municipality, 100037
About this study
Official title: A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China
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.
- Being tested
- EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
- Keywords
- Elective Major Cardiothoracic, Mitral Valve Surgery, Coronary Artery Bypass Grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight SystemDevice
EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output using the Non-invasive ClearSight System
Cardiac Output using the Non-invasive ClearSight System
Measured: Expected to last no more than 6 hours
Secondary outcomes (1)
The percentage error (PE) between the ClearSight System CO and TD
The percentage error (PE) between the ClearSight System CO and TD
Measured: Expected to last no more than 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start25 Dec 2018
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient With Clinically Indicated Invasive MonitoringStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807622
- Sponsor's protocol ID
- 2018-05
- Status last verified
- Nov 2019
- First submitted
- 15 Jan 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wang Y, Huang W, Han J, Tian Y, Wang C, Li L. A comparison of ClearSight noninvasive cardiac output and pulmonary artery bolus thermodilution cardiac output in cardiac surgery patients. Perioper Med (Lond). 2022 Jun 9;11(1):24. doi: 10.1186/s13741-022-00248-1.
PubMed 35676705
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Nonrandomized, Non-interventional Trial to Evaluate ClearSight System Cardiac Output in China
- ClinicalTrials.gov ID
- NCT03807622
- Acronym / sponsor ID
- 2018-05
- Keywords
- Elective Major Cardiothoracic, Mitral Valve Surgery, Coronary Artery Bypass Grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective major cardiothoracic surgery with an indwelling PA catheter. The surgical intervention includes, but is not limited to, mitral valve surgery or coronary artery bypass grafting.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight SystemEV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System | Device | – |
Primary outcome
Cardiac Output using the Non-invasive ClearSight System
Time frame: Expected to last no more than 6 hours
Cardiac Output using the Non-invasive ClearSight System
1 secondary outcome
The percentage error (PE) between the ClearSight System CO and TD
Time frame: Expected to last no more than 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Derived from this study: PubMed 35676705Wang Y, Huang W, Han J, Tian Y, Wang C, Li L. A comparison of ClearSight noninvasive cardiac output and pulmonary artery bolus thermodilution cardiac output in cardiac surgery patients. Perioper Med (Lond). 2022 Jun 9;11(1):24. doi: 10.1186/s13741-022-00248-1.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient With Clinically Indicated Invasive Monitoring, run by Edwards Lifesciences at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output using the Non-invasive ClearSight System (time frame: Expected to last no more than 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03807622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.