UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038114 |
|---|---|
| Receipt number | R000043435 |
| Scientific Title | The changes in perioperative cardiac function using ProAQT sensor during trans catheter aortic valve reimplantation |
| Date of disclosure of the study information | 2019/09/27 |
| Last modified on | 2023/07/06 17:09:23 |
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Basic information
Public title
The changes in perioperative cardiac function using ProAQT sensor during trans catheter aortic valve reimplantation
Acronym
The changes in perioperative cardiac function using ProAQT sensor during trans catheter aortic valve reimplantation
Scientific Title
The changes in perioperative cardiac function using ProAQT sensor during trans catheter aortic valve reimplantation
Scientific Title:Acronym
The changes in perioperative cardiac function using ProAQT sensor during trans catheter aortic valve reimplantation
Region
| Japan |
Condition
Condition
severe aortic stenosis
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To try the optimization of hemodynamics and fluid management of severe aortic stenosis by used ProAQT sensor during transcatheter aortic valve implantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The preoperative changes in cardiac index and stroke volume index during transcatheter aortic valve implantation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients of severe aortic stenosis scheduled to transcatheter aortic valve implantation
Key exclusion criteria
If the consent from the participants or their family is not acquired, they will be excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mitutaka |
| Middle name | |
| Last name | Edanaga |
Organization
Sapporo medical university school of medicine
Division name
Department of anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Nakano |
Organization
Sapporo medical university school of medicine
Division name
Hospital section
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
ji-rskk@sapmed.ac.jpj
Sponsor or person
Institute
Sapporo medical university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo medical university school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo medical university school of medicine
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
ji-rskk@sapmed.ac.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
| 2019 | Year | 09 | Month | 27 | 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
43
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
| 2019 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we will perform prospective observational study. Primary outcome is changes in perioperative hemodynamics during transcatheter aortic valve reimplantation.
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043435
