UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039041 |
|---|---|
| Receipt number | R000044522 |
| Scientific Title | Folding Plasty versus Triangular resection for posterior leaflet prolapse |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/07/02 12:23:51 |
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Basic information
Public title
Folding Plasty versus Triangular resection for posterior leaflet prolapse
Acronym
Folding Plasty versus Triangular resection
for posterior leaflet prolapse
Scientific Title
Folding Plasty versus Triangular resection
for posterior leaflet prolapse
Scientific Title:Acronym
Folding Plasty versus Triangular resection
for posterior leaflet prolapse
Region
| Japan |
Condition
Condition
Mitral valve regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compared the results of the early outcome between triangular resection and folding repair and examined their effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Reoperation
Key secondary outcomes
Re-occurrence of Mitral regurgitation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mitral valve folding repair
Interventions/Control_2
Mitral valve triangular resection repair
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
Single Mitral valve posterior repair
Key exclusion criteria
multiple valve operation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KEN |
| Middle name | |
| Last name | NAKAMURA |
Organization
Saitama Cardiovascular and Respiratory Center
Department of Cardio vascular Surgery
Division name
Cardiac Surgery
Zip code
360-0197
Address
1696, Itai, Kumagaya-shi, Saitama, Japan
TEL
+81485369920
cardiacsurgken@ybb.ne.jp
Public contact
Name of contact person
| 1st name | KEN |
| Middle name | |
| Last name | NAKAMURA |
Organization
Saitama Cardiovascular and Respiratory Center
Division name
Cardiac Surgery
Zip code
360-0197
Address
1696, Itai, Kumagaya-shi, Saitama, Japan
TEL
+81485369920
Homepage URL
cardiacsurgken@ybb.ne.jp
Sponsor or person
Institute
Saitama Cardiovascular and Respiratory Center
Cardiac Surgery
Institute
Department
Personal name
Funding Source
Organization
Saitama Cardiovascular and Respiratory Center
Cardiac Surgery
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
Saitama Cardiovascular and Respiratory Center Cardiac Surgery
Address
1696, Itai, Kumagaya-shi, Saitama, Japan
Tel
+81485369920
cardiacsurgken@ybb.ne.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
埼玉県立循環器・呼吸器病センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | 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
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 01 | Day |
Last modified on
| 2020 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044522
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
