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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025515
Receipt No. R000029354
Scientific Title Postoperative prognosis of mitral valve repair due to the difference in mitral annular measurement between sizer and transesophageal echocardiography
Date of disclosure of the study information 2017/03/01
Last modified on 2018/12/11

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Basic information
Public title Postoperative prognosis of mitral valve repair due to the difference in mitral annular measurement between sizer and transesophageal echocardiography
Acronym Postoperative prognosis of mitral valve repair due to the difference in mitral annular measurement between sizer and transesophageal echocardiography
Scientific Title Postoperative prognosis of mitral valve repair due to the difference in mitral annular measurement between sizer and transesophageal echocardiography
Scientific Title:Acronym Postoperative prognosis of mitral valve repair due to the difference in mitral annular measurement between sizer and transesophageal echocardiography
Region
Japan

Condition
Condition mitral valve repair for mitral regurgitation
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this retrospective study is to evaluate whether the discrepancy between the TEE under beating heart and the sizer under the cardioplegic arrested heart affect long-term clinical outcomes of mitral annuloplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the long term progressive of mitral regurgitation and discrepancy (3D-TEE and size of annuloplasty ring)
Key secondary outcomes Degree of the postoperative mitral regurgitation
Degree of the postoperative mitral stenosis
Prediction of annuloplasty ring size using TEE

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergone mitral valve repair from January,2015 to December, 2016
Patients with more than 20 years old
Key exclusion criteria emergency operation
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Ohnishi
Organization National Cerebral and Cardiovascular Center
Division name Department of Anesthesiology
Zip code
Address 5-7-1 fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Email yonishi@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Fujii
Organization National Cerebral and Cardiovascular Center
Division name Department of Anesthesiology
Zip code
Address 5-7-1 fujishirodai, Suita, Osaka, Japan
TEL 06-6833-5012
Homepage URL
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization National Cerebral and Cardiovascular Center
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
2017 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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective singlecenter study

Management information
Registered date
2017 Year 01 Month 04 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029354

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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