UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047492 |
|---|---|
| Receipt number | R000054159 |
| Scientific Title | A Registry Study of the Efficacy and Safety of Percutaneous Mitral Regurgitation Repair for Mitral Regurgitation |
| Date of disclosure of the study information | 2022/04/15 |
| Last modified on | 2022/04/16 00:15:52 |
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Basic information
Public title
A Registry Study of the Efficacy and Safety of Percutaneous Mitral Regurgitation Repair for Mitral Regurgitation
Acronym
A Registry Study of the Efficacy and Safety of Percutaneous Mitral Regurgitation Repair for Mitral Regurgitation
Scientific Title
A Registry Study of the Efficacy and Safety of Percutaneous Mitral Regurgitation Repair for Mitral Regurgitation
Scientific Title:Acronym
A Registry Study of the Efficacy and Safety of Percutaneous Mitral Regurgitation Repair for Mitral Regurgitation
Region
| Japan |
Condition
Condition
Mitral Regurgitation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish a registry for percutaneous mitral valve repair in patients who have undergone or will undergo percutaneous edge-to-edge mitral valve repair at our hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of percutaneous edge-to-edge mitral valve repair
Key secondary outcomes
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
Persons who does not refuse to participate in this research from the research subject or from a person who is deemed able to represent the research subject's wishes and interests
Key exclusion criteria
Persons deemed inappropriate as research subjects by the principal investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nagai |
Organization
Hokkaido University Hospital
Division name
Cardiology
Zip code
060-8638
Address
Kita 15-jo Nishi 7-chome Kita-ku, Sapporo Japan
TEL
011-706-6973
nagai@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Mizuguchi |
Organization
Hokkaido University Hospital
Division name
Cardiology
Zip code
060-8638
Address
Kita 15-jo Nishi 7-chome Kita-ku, Sapporo Japan
TEL
011-706-6973
Homepage URL
mizu-tay@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
Hokkaido University Hospital
Address
Kita 15-jo Nishi 7-chome Kita-ku, Sapporo Japan
Tel
011-706-6973
mizu-tay@med.hokudai.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
| 2022 | Year | 04 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect medical information on research subjects for 5 years
Management information
Registered date
| 2022 | Year | 04 | Month | 14 | Day |
Last modified on
| 2022 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054159
