UMIN-CTR Clinical Trial

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
Email	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
Email	iwai@wch.opho.jp

Sponsor
Institute	Osaka Women's and Children's Hospital Department of Cardiovascular Surgery
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053380