UMIN-CTR Clinical Trial

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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