UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037261 |
|---|---|
| Receipt number | R000042483 |
| Scientific Title | Epolatory for assessment of the effect with percutaneous mitral valve repair |
| Date of disclosure of the study information | 2019/07/28 |
| Last modified on | 2019/07/27 21:10:29 |
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Basic information
Public title
Epolatory for assessment of the effect with percutaneous mitral valve repair
Acronym
Epolatory for assessment of the effect with percutaneous mitral valve repair
Scientific Title
Epolatory for assessment of the effect with percutaneous mitral valve repair
Scientific Title:Acronym
Epolatory for assessment of the effect with percutaneous mitral valve repair
Region
| Japan |
Condition
Condition
mitral valve regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to identify mortality or morbidity after the percutaneous mitral valve repair
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
all cause death
Key secondary outcomes
heart failure re-hospitalization
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing mitral valve repair due to mitral valve regurgitation
Key exclusion criteria
Patients with non-heart disease and estimated life expectancy less than 1 year
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHIRO |
| Middle name | |
| Last name | AKASHI |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology
Zip code
216-8511
Address
1-16-2 sugao miyamaeku kawasaki kanagwa
TEL
0449778111
johnny@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | SHUNICHI |
| Middle name | |
| Last name | DOI |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology
Zip code
216-8511
Address
1-16-2 sugao miyamaeku kawasaki kanagwa
TEL
0449778111
Homepage URL
s2doi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
1-16-2 sugao miyamaeku kawasaki kanagwa
Tel
0449778111
s2doi@marianna-u.ac.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
| 2019 | Year | 07 | Month | 28 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042483
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
