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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001640
Receipt No. R000001972
Scientific Title Long-term results of SJM mechanical valve
Date of disclosure of the study information 2009/01/16
Last modified on 2011/07/16

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Basic information
Public title Long-term results of SJM mechanical valve
Acronym Long-term results of SJM mechanical valve
Scientific Title Long-term results of SJM mechanical valve
Scientific Title:Acronym Long-term results of SJM 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 SJM mechanical valve.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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 300

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 Oyagichi kami-machi, Itabashi-ku, Tokyo
TEL
Email

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
Email

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization self funding
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
Email

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 16 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 16 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
2020 Year 12 Month 01 Day
Date trial data considered complete
2020 Year 12 Month 01 Day
Date analysis concluded
2020 Year 12 Month 01 Day

Other
Other related information retrospecive study

Management information
Registered date
2009 Year 01 Month 16 Day
Last modified on
2011 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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