UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011193 |
|---|---|
| Receipt number | 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 10:29:43 |
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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
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
Alpineskierjp@aol.com
Sponsor or person
Institute
Deparment of General and Cardiothoracic Surgery, Graduate School of Medicine, Gifu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
