UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040255 |
|---|---|
| Receipt number | R000045921 |
| Scientific Title | The investigation related perioperative circulatory fluctuation during transcatheter aortic valve implantation and the predictive factors. |
| Date of disclosure of the study information | 2020/04/30 |
| Last modified on | 2020/04/27 18:59:55 |
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Basic information
Public title
The investigation related perioperative circulatory fluctuation during transcatheter aortic valve implantation and the predictive factors.
Acronym
The investigation related perioperative circulatory fluctuation during transcatheter aortic valve implantation and the predictive factors.
Scientific Title
The investigation related perioperative circulatory fluctuation during transcatheter aortic valve implantation and the predictive factors.
Scientific Title:Acronym
The investigation related perioperative circulatory fluctuation during transcatheter aortic valve implantation and the predictive factors.
Region
| Japan |
Condition
Condition
Severe aortic valve stenosis
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence of the ventricular filling pressure change and the predictive factors during TAVI procedure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative ventricular filling pressure change and the perioperative influential factor during TAVI procedure
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
Patients who had undergone a TAVI procedure between February 2017 and January 2020
Key exclusion criteria
Patients who required a percutaneous cardiopulmonary support device or intra-arterial balloon pumping perioperatively, subjects who required additional surgical procedure because of intraoperative complication, subjects who transited to emergent cardiac surgery, subjects with insufficient recorded data.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kosaku |
| Middle name | |
| Last name | Toyota |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
+8186-422-0210
kt15613@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Kosaku |
| Middle name | |
| Last name | Toyota |
Organization
Kurashiki Central Hospital
Division name
Department of Anesthesiology
Zip code
710-8602
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL
+8186-422-0210
Homepage URL
kt15613@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital (Ohara HealthCare Foundation)
Institute
Department
Personal name
Funding Source
Organization
None
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
Kurashiki Central Hospital Ethics Committee
Address
1-1-1 Miwa, Kurashiki, Okayama, Japan
Tel
086-422-0210
kenkyu@kchnet.or.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
| 2020 | Year | 04 | Month | 30 | 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
196
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 04 | Month | 27 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045921
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| Registered date | File name |
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