UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021039 |
|---|---|
| Receipt number | R000019546 |
| Scientific Title | Safety and feasibility study of aortic valve reconstruction with autologous pericardium. |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2020/09/18 15:12:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety and feasibility study of aortic valve reconstruction with autologous pericardium.
Acronym
Study of arotic valve reconstruction with autologous pericardium.
Scientific Title
Safety and feasibility study of aortic valve reconstruction with autologous pericardium.
Scientific Title:Acronym
Study of arotic valve reconstruction with autologous pericardium.
Region
| Japan |
Condition
Condition
Aortic valve steosis, aortic valve regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To access the safety and feasibility of the aortic valve reconstruction with autologous pericardium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Reoperation free rate 3 years after operation.
Key secondary outcomes
Aortic valve malfunction free rate for 3 year after operation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Aortic valve reconstruction with autologous pericardium
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
1) Patients with aortic stenosis or aortic regurgitation with indication of aortic valve replacement.
2) indicated for conventional cardiopulmonary bypass.
3) with informed consent.
Key exclusion criteria
1) Patients who needs concomitant aditional mitral valve operation or aortic surgery.
2) with severe aortic calcification.
3) with hemodyalysis
4) patients who deemed inappropriate for aortic valve repair.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shibata Toshihiko |
Organization
Osaka City University Graduate School of Medicine
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
1-4-3 Asahimachi, Abenoku, Osaka
TEL
06-6645-3980
shibata-cvs@zeus.eonet.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shibata Toshihiko |
Organization
Osaka City University Graduate School of Medicine
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
1-4-3 Asahimachi, Abenoku, Osaka
TEL
06-6645-3980
Homepage URL
shibata-cvs@zeus.eonet.ne.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine, Dept. of Cardiovascular 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
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
Osaka City University Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2016 | Year | 02 | Month | 15 | Day |
Last modified on
| 2020 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019546
