UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056472 |
|---|---|
| Receipt number | R000064534 |
| Scientific Title | The Efficiency and Safety of MitraClip in secondary mitral regurgitation: A Systematic Review and Meta-analysis of Randomized Clinical Trials |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2025/05/07 10:50:18 |
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Basic information
Public title
The Efficiency and Safety of MitraClip in secondary mitral regurgitation: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Acronym
The Efficiency and Safety of MitraClip in secondary mitral regurgitation: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Scientific Title
The Efficiency and Safety of MitraClip in secondary mitral regurgitation: A Systematic Review and Meta-analysis of Randomized Clinical Trials
Scientific Title:Acronym
MitraClip in MR
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Secondary mitral regurgitation
Classification by specialty
| Medicine in general | Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the safety and effectiveness of MitraClip in secondary MR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Rehospitalization
2. Mortality
3. Functionary recovery
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1. RCT
2. MitraClip vs surgery
3. Outcome available
Key exclusion criteria
1. Single arm
2. Not clinical trial
3. Review
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Zaiqiang |
| Middle name | |
| Last name | Yu |
Organization
Thoracic and Cardiovascular Surgery, Hirosaki University
Division name
Thoracic and Cardiovascular Surgery
Zip code
036-8224
Address
1 Bunkyocho, Hirosaki, Aomori,
TEL
0172-33-5111
yuzq@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Zaiqing |
| Middle name | |
| Last name | Yu |
Organization
Thoracic and Cardiovascular Surgery, Hirosaki University, Aomori, Japan
Division name
Thoracic and Cardiovascular Surgery
Zip code
036-8224
Address
1 Bunkyocho, Hirosaki, Aomori
TEL
0172-33-5111
Homepage URL
yuzq@hotmail.co.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University
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
Hirosaki University IRB
Address
1 Bunkyocho, Hirosaki, Aomori, 036-8224, Japan
Tel
0172-33-5111
yuzq@hotmail.co.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
| 2024 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jclinque.com/article/efficacy-and-safety-of-transcatheter-therapy-for-secondary-mitral-regur
Number of participants that the trial has enrolled
1631
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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064534
