UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044953 |
|---|---|
| Receipt number | R000051356 |
| Scientific Title | Verification of Cardiac Output Accuracy of the ClearSight System during TAVI |
| Date of disclosure of the study information | 2021/07/26 |
| Last modified on | 2021/07/26 08:51:55 |
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Basic information
Public title
Verification of Cardiac Output Accuracy of the ClearSight System during TAVI
Acronym
Verification of Cardiac Output Accuracy of the ClearSight System during TAVI
Scientific Title
Verification of Cardiac Output Accuracy of the ClearSight System during TAVI
Scientific Title:Acronym
Verification of Cardiac Output Accuracy of the ClearSight System during TAVI
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of the present study conducted in patients undergoing TAVI were as follows: to compare both ClearSight CO with CO from transpulmonary thermodilution as the reference method. We hypothesized that the ClearSight noninvasive pulse contour CO measurements could be a substitute for the invasive CO measurements during TAVI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The objectives of the present study conducted in patients undergoing TAVI were as follows: to compare both ClearSight CO with CO from transpulmonary thermodilution as the reference method. We hypothesized that the ClearSight noninvasive pulse contour CO measurements could be a substitute for the invasive CO measurements during TAVI.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients provided informed written consent
Key exclusion criteria
emergency operation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Musashi |
| Middle name | Yahagi |
| Last name | Musashi |
Organization
Hitachi general hospital
Division name
Anesthesiology
Zip code
317-0077
Address
Hitachi Jounanchou 2-1-1
TEL
0294-23-1111
musasum0710@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Musashi |
| Middle name | |
| Last name | Yahagi |
Organization
Hitachi general hospital
Division name
Anesthesiology
Zip code
3170077
Address
Hitachi Jounanchou 2-1-1
TEL
08033348696
Homepage URL
musasum0710@yahoo.co.jp
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi general hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi general hospital
Address
Hitachi Jounanchou 2-1-1
Tel
0294231111
musasum0710@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cardiac output
Management information
Registered date
| 2021 | Year | 07 | Month | 26 | Day |
Last modified on
| 2021 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051356
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| Registered date | File name |
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