UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023705 |
|---|---|
| Receipt number | R000027271 |
| Scientific Title | Transcatheter aortic valve implantation for aortic stenosis registry |
| Date of disclosure of the study information | 2016/08/21 |
| Last modified on | 2020/02/22 09:37:15 |
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Basic information
Public title
Transcatheter aortic valve implantation for aortic stenosis registry
Acronym
AS-TAVI registry
Scientific Title
Transcatheter aortic valve implantation for aortic stenosis registry
Scientific Title:Acronym
AS-TAVI registry
Region
| Japan |
Condition
Condition
Aortic stenosis
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This registry was initiated to observe and document the course of aortic stenosis, that was considered TAVI as a treatment. Especially for the cases treated by TAVI, we focus on procedural results and post-procedural outcome of TAVI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cumulative survival rate after TAVI
Key secondary outcomes
Cardiac death after TAVI
Re-admission for heart failure after TAVI
Cerebrovascular event after TAVI
Improvemtnt of NYHA classification and mean aortic gradient after TAVI
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who have aortic stenosis for which TAVI was considered in Keio University hospital.
Key exclusion criteria
The patients who are under 20 years old or who are deemed to be unfit as subjects of our survey.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Hayashida |
Organization
Keio University Hospital
Division name
Cardiology
Zip code
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
k-hayashida@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Hayashida |
Organization
Keio University Hospital
Division name
Cardiology
Zip code
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
k-hayashida@umin.ac.jp
Sponsor or person
Institute
Keio University Hospital
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
Toyohashi Heart Center
Teikyo University Hospital
Shin-tokyo Hospital
Kokura Memorial Hospital
Sendai Kousei Hospital
Shonan Kamakura Hospital
Saiseikai Yokohamashi Tobu Hospital
Ogaki Municipal Hospital
Kishiwada Tokushukai Hospital
Tokyo Bay Urayasu/Ichikawa Medical Center
Osaka City University Hospital
Toyama University Hospital
Nagoya Heart Center
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, observational study, and will last about 6 years.
Management information
Registered date
| 2016 | Year | 08 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027271
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
