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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039041
Receipt No. 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

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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
Email 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
Email cardiacsurgken@ybb.ne.jp

Sponsor
Institute Saitama Cardiovascular and Respiratory Center
Cardiac Surgery
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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