UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001636 |
|---|---|
| Receipt number | R000001967 |
| Scientific Title | Follow-up survey of ATS mechanical valve |
| Date of disclosure of the study information | 2009/01/15 |
| Last modified on | 2010/03/14 13:16:16 |
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Basic information
Public title
Follow-up survey of ATS mechanical valve
Acronym
Follow-up survey of ATS mechanical valve
Scientific Title
Follow-up survey of ATS mechanical valve
Scientific Title:Acronym
Follow-up survey of ATS mechanical valve
Region
| Japan |
Condition
Condition
Patients of valve replacement using ATS mechanical valve
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research has aimed to evaluate the long-term result of ATS mechanical valve.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
valve-related complication
Key secondary outcomes
mortality, cause of death, echocardiograhic data,LDH
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
valve disease
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University Itabashi Hosipial
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nihon University school of medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nihon University Itabashi Hosipial
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
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
| 2009 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2009 | Year | 01 | Month | 15 | Day |
Last modified on
| 2010 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001967
