UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018396 |
|---|---|
| Receipt number | R000021303 |
| Scientific Title | Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2018/09/13 09:37:37 |
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Basic information
Public title
Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients
Acronym
Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients
Scientific Title
Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients
Scientific Title:Acronym
Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients
Region
| Japan |
Condition
Condition
congenital heart disease with pulmonary valve insuffucency
Classification by specialty
| Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the decellulerized heart valve after transplantation for pulmonary valve insufficiency congenital heart disease patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the safety and durability of the transplanted decellularized heart valve 3 month after the transplantation
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
pulmonary valve transplantation with decellularized heart valve for pulmonary valve insufficiency congenital heart disease patients
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
Indication for pulmonary valve replacement according to current medical guidelines
in congenital heart disease
Informed consent of parents (both) or patients, assent of patients (<18 years)
Key exclusion criteria
The patient has not provided Study informed consent.
The patient has active endocarditis (within the last 3 month).
The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyreoidism).
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Osaka University hospital
Division name
Cardiovascular surgery
Zip code
Address
2-15 Yamadaoka,suita,Osaka
TEL
06-6879-3154
sawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto Ozawa |
Organization
Osaka University hospital
Division name
Cardiovascular surgery
Zip code
Address
2-15 Yamadaoka,suita,Osaka
TEL
06-6879-3154
Homepage URL
h-ozawa@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
| 2015 | Year | 07 | Month | 23 | 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
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | 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
| 2015 | Year | 07 | Month | 23 | Day |
Last modified on
| 2018 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021303
