UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025793 |
|---|---|
| Receipt number | R000029375 |
| Scientific Title | Prediction of the annuloplasty ring size for mitral valve repair using by three-dimensional transesophageal echocardiography |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2021/01/07 14:10:56 |
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Basic information
Public title
Prediction of the annuloplasty ring size for mitral valve repair using by three-dimensional transesophageal echocardiography
Acronym
Prediction of the annuloplasty ring size for mitral valve repair using by three-dimensional transesophageal echocardiography
Scientific Title
Prediction of the annuloplasty ring size for mitral valve repair using by three-dimensional transesophageal echocardiography
Scientific Title:Acronym
Prediction of the annuloplasty ring size for mitral valve repair using by three-dimensional 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 study is to compare the mitral annual size by measurements between 3D-TEE and sizer, and assessed whether the size of mitral annuloplasty ring can be predicted by 3D-TEE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the size of annuloplasty ring size and predicted size by using 3D-TEE
Key secondary outcomes
Evaluate whether the discrepancy between the annuloplasty ring size and predicted size by using 3D-TEE affect the postoperative residual mitral regurgitation.
Correlation between the size of annuloplasty ring size and predicted size by using 3D-TEE due to the difference of the lesion site (anterior leaflet or posterior leaflet)
Complication of transesophageal echocardiography
Postoperative complication
Postoperative recovery (respiration time, stay in intensive care unit, hospital stay)
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
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
plus9@med.nagoya-u.ac.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
| 2021 | Year | 03 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029375
