UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026020 |
|---|---|
| Receipt number | R000029911 |
| Scientific Title | Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2022/05/29 13:05:48 |
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Basic information
Public title
Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study
Acronym
Stentless mitral valve replacement: pilot study
Scientific Title
Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study
Scientific Title:Acronym
Stentless mitral valve replacement: pilot study
Region
| Japan |
Condition
Condition
mitral valve stenosis, mitral valve stenosis and regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of the autologous pericardial stentless mitral valve replacement. This study is pilot study for future multi-institutional study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of mitral valve regurgitation 2 weeks after surgery
Key secondary outcomes
Presence of adverse event wiyhin 12 months after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Autologous pericardial stentless mitral valve replacement
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.severe mitral stenosis, or mitral stenosis and regurgitation, no indication of valve plasty.
2. no indication for catheter intervention treatment
3. mitral valve stenosis: post mitral valve replacement using bioprosthetic valve.
4. mitral valve stenosis: post mitral valve replacement using mechanical valve.
5. Congenital mitral valve stenosis.
Key exclusion criteria
1. Malignancy
2. Hemodialysis
3. Included other clinical study
4. Myocardial infarction within 6 months
5. Strole within 6 months
6. Coronary intervention within 1 months
7. Indication for other cardiac diseases (tricuspid, atrial fibrillation excluded)
8. sever left ventricular dysfunction
9. Conventional treatment is expected to be the best.
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Yaku |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular surgery
Zip code
6028566
Address
465 Kajiicho Kamigyo Kyoto
TEL
0752515752
yakuh@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Numata |
Organization
Kyoto Prefectural University of Medicine
Division name
Cardiovascular surgery
Zip code
6028566
Address
465 Kajiicho Kamigyo Kyoto
TEL
0752515752
Homepage URL
snumat@yahoo.co.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board, Kyoto Prefectural University of Medicine.
Address
465 Kajiicho Kamigyo Kyoto JAPAN
Tel
0752515337
kpu@bvits.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
京都府立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 31 | 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
0
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 06 | Day |
Last modified on
| 2022 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029911
