UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046796 |
|---|---|
| Receipt number | R000053380 |
| Scientific Title | Examination of aortic arch reconstruction method in the Norwood procedure |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/02/01 17:19:48 |
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Basic information
Public title
Examination of aortic arch reconstruction method in the Norwood procedure
Acronym
Examination of aortic arch reconstruction method in the Norwood procedure
Scientific Title
Examination of aortic arch reconstruction method in the Norwood procedure
Scientific Title:Acronym
Examination of aortic arch reconstruction method in the Norwood procedure
Region
| Japan |
Condition
Condition
Hypoplastic left heart syndrome
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Neoaortic posterior wall plication as a novel aortic arch reconstruction method in Norwood procedure could decrease the risk of postoperative complications compared to the conventional method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological assessment of aortic arch reconstruction by imaging examination 1 year after Norwood procedure.
Key secondary outcomes
Pulmonary stenosis, bronchial stenosis, and aortic valve regurgitation at last follow-up.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with hypoplastic left heart syndrome variants who have been followed up for more than 6 months after the Norwood procedure since 2010 at Osaka Women's and Children's Hospital.
Key exclusion criteria
Patients who underwent neoaortic valve repair concurrently with the Norwood procedure
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Shigemitsu |
| Middle name | |
| Last name | Iwai |
Organization
Osaka Women's and Children's Hospital
Division name
Cardiovascular Surgery
Zip code
594-1101
Address
840 Murodo-cho Izumi, Osaka
TEL
0725-56-1220
iwai@wch.opho.jp
Public contact
Name of contact person
| 1st name | Shigemitsu |
| Middle name | |
| Last name | Iwai |
Organization
Osaka Women's and Children's Hospital
Division name
Cardiovascular Surgery
Zip code
594-1101
Address
840 Murodo-cho Izumi, Osaka
TEL
0725-56-1220
Homepage URL
iwai@wch.opho.jp
Sponsor or person
Institute
Osaka Women's and Children's Hospital
Department of Cardiovascular Surgery
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
Osaka Women's and Children's Hospital
Address
840 Murodo-cho Izumi, Osaka
Tel
0725-56-1220
iwai@wch.opho.jp
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
大阪母子医療センター(大阪府)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | 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
31
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | 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
The medical records of all 31 patients who underwent Norwood procedure at Osaka Women's and Children's Hospital since 2010 were retrospectively reviewed about early and mid-term outcomes.
Management information
Registered date
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053380
