UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040413 |
|---|---|
| Receipt number | R000046115 |
| Scientific Title | International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura) |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2022/05/25 10:29:43 |
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Basic information
Public title
International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)
Acronym
International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)
Scientific Title
International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)
Scientific Title:Acronym
International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)
Region
| Japan | Europe |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is that the long term outcomes (> 10 years) after TAVI. The other purpose of this study is that to establish predictive model for early clinical event.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
long term (> 10 years) outcomes (mortality, durability of THV and late cardiovascular event other than mortality)
Key secondary outcomes
establish predictive model for early clinical event (stroke, bleeding etc)
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 who underwent or undergo trans catheter aortic valve implantation for aortic stenosis.
Key exclusion criteria
none
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Saito |
Organization
Shonan Kamakura general Hospital
Division name
Department of Cardiology
Zip code
247-8533
Address
Okamoto 1370-1, Kamakura, Japan
TEL
0467-46-1717
transradial@kamakuraheart.org
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Moriyama |
Organization
Shonan Kamakura general Hospital
Division name
Department of Cardiology
Zip code
247-8533
Address
Okamoto 1370-1, Kamakura, Japan
TEL
0467-46-1717
Homepage URL
e2718nm@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital
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
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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 | 05 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2022 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046115
