UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017814 |
|---|---|
| Receipt number | R000020639 |
| Scientific Title | Change of Mitral Valve shape during the procesure of Transcatheter Aortic Valve Inplantation |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2015/06/04 16:56:27 |
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Basic information
Public title
Change of Mitral Valve shape during the procesure of Transcatheter Aortic Valve Inplantation
Acronym
Change of MV shape during TAVI
Scientific Title
Change of Mitral Valve shape during the procesure of Transcatheter Aortic Valve Inplantation
Scientific Title:Acronym
Change of MV shape during TAVI
Region
| Japan |
Condition
Condition
aortic valve stenosis
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bei obsevation of mitral valve shape during transcatheter aortic valve inplantation,evaluate the risk of mitral regargitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
mitral valve shape with transesophageal echocardiogrphy
Key secondary outcomes
amount of mitral regurgitation
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
Patient with TAVI
Key exclusion criteria
Patient withaut agreement
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Ariyama |
Organization
Saitama Medical University International Medical Center
Division name
Department of anathesiology
Zip code
Address
1397-1Yamane,Hidaka-city,Saitama
TEL
0429844394
nqe39252@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Ariyama |
Organization
Saitama InternationaMedical University l Medical Center
Division name
Department of anathesiology
Zip code
Address
1397-1Yamane,Hidaka-city,Saitama
TEL
0429844394
Homepage URL
nqe39252@nifty.com
Sponsor or person
Institute
Saitama InternationaMedical University l Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama InternationaMedical University l Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 15 | 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
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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
we are ready to start this Reseach,as soon as we can 3D-TEE available.
Management information
Registered date
| 2015 | Year | 06 | Month | 04 | Day |
Last modified on
| 2015 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020639
