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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045637
Receipt No. R000052102
Scientific Title Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Date of disclosure of the study information 2021/10/04
Last modified on 2021/10/01

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Basic information
Public title Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Acronym Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Scientific Title Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Scientific Title:Acronym Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Region
Japan

Condition
Condition mitral valve regurgitation
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We reviewed early and mid-term outcome of the patients underwent mitral valve surgery for moderate or more mitral valve regurgitation in less than 12 months old.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death at last follow-up.
Key secondary outcomes Reoperation, mitral valve replacement and moderate or more mitral valve regurgitation at last follow-up.

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

Not applicable
Age-upper limit
12 months-old >
Gender Male and Female
Key inclusion criteria Patients less than 12 months old who underwent mitral valve surgery for moderate or more mitral valve regurgitation at Hyogo prefectural Amagasaki general medical center from October 2005 to March 2019.
Key exclusion criteria Patients of 1 year old or older. Patients with atrioventricular septal defect, functional single ventricle, atrioventricular and/or ventriculoarterial discordance, and dominance of atrioventricular valve stenosis.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name Toshi
Middle name
Last name Maeda
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Cardiovascular Surgery
Zip code 660-8550
Address 2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
TEL +81-6-6480-7000
Email tmsirius825@gmail.com

Public contact
Name of contact person
1st name Toshi
Middle name
Last name Maeda
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Cardiovascular Surgery
Zip code 660-8550
Address 2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
TEL +81-6-6480-7000
Homepage URL
Email tmsirius825@gmail.com

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization Self funding
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 Hyogo Prefectural Amagasaki General Medical Center
Address 2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
Tel +81-6-6480-7000
Email tmsirius825@gmail.com

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
2021 Year 10 Month 04 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 18
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 No longer recruiting
Date of protocol fixation
2005 Year 10 Month 01 Day
Date of IRB
2021 Year 06 Month 16 Day
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The medical records of all 18 patients less than 12 months old who underwent mitral valve surgery for moderate or more mitral valve regurgitation at Hyogo prefectural Amagasaki general medical center between October 2005 and March 2019 were retrospectively reviewed about early and mid-term outcomes.

Management information
Registered date
2021 Year 10 Month 01 Day
Last modified on
2021 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052102

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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