UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017998 |
|---|---|
| Receipt number | R000020036 |
| Scientific Title | Examination of the degree of difficulty involved in the surgical procedure of Minimally Invasive Mitral Valve Repair. |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/06/22 02:01:13 |
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Basic information
Public title
Examination of the degree of difficulty involved in the surgical procedure of Minimally Invasive Mitral Valve Repair.
Acronym
Examination of the degree of difficulty involved in the surgical procedure of Minimally Invasive Mitral Valve Repair.
Scientific Title
Examination of the degree of difficulty involved in the surgical procedure of Minimally Invasive Mitral Valve Repair.
Scientific Title:Acronym
Examination of the degree of difficulty involved in the surgical procedure of Minimally Invasive Mitral Valve Repair.
Region
| Japan |
Condition
Condition
Mitral Valve Regurgitation
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the degree of difficulty involved in surgical procedures of Minimally Invasive Mitral Valve Repair.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the degree of difficulty involved in surgical procedures of Minimally Invasive Mitral Valve Repair by using score sheet.
Key secondary outcomes
-Cardiac arrest time
-Conversion from the MICS MVP to a conventional one
-Mitral valve regurgitation (degree of the MR, MR jet area) by intraoperative transesophageal echocardiography
-Mitral valve regurgitation (degree of the MR, MR jet area) by transesophageal echocardiography after operation
-Survival
-Major complication
-Time and the number of times that we needed by success of each surgical procedure of the MICS MVP
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
the patient who take operation of Minimally Invasive Mitral Valve Repair to care mitral valve regurgitation.
Key exclusion criteria
emergency case and complex operation with mital valve
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Shimizu |
Organization
Department of Surgery, Keio University School of Medicine, Tokyo, Japan
Division name
Division of Cardiovascular Surgery
Zip code
Address
35 shinanomachi shinjuku-ku Tokyo, 160-8582, Japan
TEL
03-3353-1211
shimizu.md@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuma Okamoto |
Organization
Department of Surgery, Keio University School of Medicine, Tokyo, Japan
Division name
Division of Cardiovascular Surgery
Zip code
Address
35 shinanomachi shinjuku-ku Tokyo, 160-8582, Japan
TEL
03-3353-1211
Homepage URL
okamoto-kazuma@mac.com
Sponsor or person
Institute
Division of Cardiovascular Surgery, Department of Surgery, Keio University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 06 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020036
