UMIN-CTR Clinical Trial

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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