UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031133 |
|---|---|
| Receipt number | R000035566 |
| Scientific Title | Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2023/08/10 13:16:29 |
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Basic information
Public title
Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry
Acronym
Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry
Scientific Title
Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry
Scientific Title:Acronym
Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry
Region
| Japan |
Condition
Condition
aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality
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 underwent transcatheter aortic valve implantation
Key exclusion criteria
patient refusal
Target sample size
7000
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Higuchi |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
1830003
Address
3-16-1 Asahi-cho, Fuchu, Tokyo, Japan
TEL
042-314-3111
rhiguchi@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Higuchi |
Organization
Sakakibara Heart Institute
Division name
Department of Cardiology
Zip code
1830003
Address
3-16-1 Asahi-cho, Fuchu, Tokyo, Japan
TEL
042-314-3111
Homepage URL
rhiguchi@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Sakakibara Clinical Research Grant for Promotion of Sciences
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakakibara Heart Institute
Address
Asahi-cho3-16-1, Fuchu, Tokyo
Tel
0423143111
rhiguchi@shi.heart.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
順天堂医院、三重大学医学部付属病院、山形大学医学部附属病院、弘前大学医学部附属病院、川崎幸病院、東邦大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
| 2017 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2038 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multi-center registry
Management information
Registered date
| 2018 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035566
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
