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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011193
Receipt No. R000013115
Scientific Title A novel aortic valve reconstruction with autologous pericardium for aortic valve disease
Date of disclosure of the study information 2013/07/16
Last modified on 2013/07/16

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Basic information
Public title A novel aortic valve reconstruction with autologous pericardium for aortic valve disease
Acronym A novel aortic valve reconstruction with pericardium for aortic valve disease
Scientific Title A novel aortic valve reconstruction with autologous pericardium for aortic valve disease
Scientific Title:Acronym A novel aortic valve reconstruction with pericardium for aortic valve disease
Region
Japan

Condition
Condition Aortic valve stenosis and/or regurgitation
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the feasibility of a novel aortic valve reconstruction with autologous pericardium for aortic valve disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Postoperative pressure gradient between left ventricle and aorta, aortic valve area, grade of aortic valve regurgitation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 To determine the feasibility of a novel aortic valve reconstruction with autologous pericardium for aortic valve disease
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 The patient with the operative indication for aortic valve stenosis and/or regurgitation, and written informed consent was obtained.
Key exclusion criteria Written informed consent was not obtained.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Takemura
Organization Graduate School of Medicine, Gifu University
Division name Deparment of General and Cardiothoracic Surgery
Zip code
Address 1-1 Yanagido, Gifu city, Japan
TEL 058-230-6325
Email

Public contact
Name of contact person
1st name
Middle name
Last name Narihiro Ishida
Organization Graduate School of Medicine, Gifu University
Division name Deparment of General and Cardiothoracic Surgery
Zip code
Address 1-1 Yanagido, Gifu city, Japan
TEL 058-230-6325
Homepage URL
Email Alpineskierjp@aol.com

Sponsor
Institute Deparment of General and Cardiothoracic Surgery, Graduate School of Medicine, Gifu University
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2013 Year 07 Month 16 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
2013 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 16 Day
Last modified on
2013 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013115

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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