UMIN-CTR Clinical Trial

Basic information
Public title	Postoperative prognosis of mitral valve repair due to the morphological change of mitral valve by using transesophageal echocardiography
Acronym	Postoperative prognosis of mitral valve repair due to the morphological change of mitral valve
Scientific Title	Postoperative prognosis of mitral valve repair due to the morphological change of mitral valve by using transesophageal echocardiography
Scientific Title:Acronym	Postoperative prognosis of mitral valve repair due to the morphological change of mitral valve
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 study is to clarify whether the morphological change of mitral valve by mitral valve repair affects postoperative prognosis by using 3D-TEE.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between the morphology change (e.g. AP diameter, AL-PM diameter, non-planar angle, annulus area, annulus hight) of mitral valve and long-term prognosis (progression of residual regurgitation at 12-24 months after surgery).
Key secondary outcomes	Degree of residual regurgitation immediately and at 12-24 months after mitral valve repair. Correlation between the site of residual mitral valve regurgitation and long-term prognosis (progression of residual regurgitation at 12-24 months after surgery). Correlation between the size of mitral annuloplasty ring and long-term prognosis (progression of residual regurgitation at 12-24 months after surgery).

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	Written informed consent is obtained from the patient or his/her parental authority Patients scheduled mitral valve repair for mitral regurgitation Patients with more than 20 years old
Key exclusion criteria	Emergency operation Patients under 20 years old Patients with mitral regurgitation due to infection (infective endocarditis) Patients contraindicated for transesophageal echocardiography (postoperative esophageal cancer, esophageal diverticulum, esophageal varix) Patients deemed as inappropriate for participating in the study Pationts who we can not take consent
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yoshihiko Middle name Last name Ohnishi
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Anesthesiology
Zip code	564-8565
Address	6-1 Kishibeshinmachi, Suita, Osaka, Japan
TEL	06-6833-5012
Email	yonishi@ncvc.go.jp

Public contact
Name of contact person	1st name Tasuku Middle name Last name Fujii
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Anesthesiology
Zip code	564-8565
Address	6-1 Kishibeshinmachi, 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	National Cerebral and Cardiovascular Center
Address	6-1 Kishibeshinmachi, Suita, Osaka, Japan
Tel	06-6833-5012
Email	plandiv@ml.ncvc.go.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

Other administrative information
Date of disclosure of the study information	2017 Year 04 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	50
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	Completed
Date of protocol fixation	2017 Year 01 Month 01 Day
Date of IRB	2017 Year 02 Month 24 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational singlecenter study

Management information
Registered date	2017 Year 01 Month 22 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029663