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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036649
Receipt No. R000041750
Scientific Title Safety and feasibility study of fetal cardiac intervention for critical aortic stenosis
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/04

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Basic information
Public title Safety and feasibility study of fetal cardiac intervention for critical aortic stenosis
Acronym Feasibility study of fetal intervention for critical aortic stenosis
Scientific Title Safety and feasibility study of fetal cardiac intervention for critical aortic stenosis
Scientific Title:Acronym Feasibility study of fetal intervention for critical aortic stenosis
Region
Japan

Condition
Condition critical aortic stenosis
Classification by specialty
Cardiology Obsterics and gynecology Pediatrics
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and feasibility of fetal cardiac intervention for critical aortic stenosis.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The rates of completing protocol therapy without severe adverse events
Key secondary outcomes The number and grade of adverse events by protocol therapy

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 No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Fetal aortic valvuloplasty for critical aortic stenosis
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
45 years-old >
Gender Female
Key inclusion criteria [Maternal criteria]
Between 22+0 and 31+6 weeks gestation
Pregnant women who have no severe complication or symptom of preterm labor
[Fetal criteria]
Fetal critical aortic stenosis without small left ventricle
Z score of LV long-axis dimension >-2
Threshold score 4 or 5
No other severe anomalies
Key exclusion criteria Pregnant women who have infectious diseases required treatments
Pregnant women who have severe psychological disorder
American Society of Anesthesiology (ASA) Physical Status Classification Class 3, 4, 5 or 6
Multiple pregnancy
Severe obesity (BMI >35)
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Haruhiko
Middle name
Last name Sago
Organization National Center for Child Health and Development
Division name Center for Maternal-fetal, Neonatal and Reproductive Medicine
Zip code 157-8535
Address 2-10-1 Okura, Setagaya, Tokyo, Japan
TEL 03-3416-0181
Email sagou-h@ncchd.go.jp

Public contact
Name of contact person
1st name Seiji
Middle name
Last name Wada
Organization National Center for Child Health and Development
Division name Division of Fetal Medicine
Zip code 157-8535
Address 2-10-1 Okura, Setagaya, Tokyo, Japan
TEL 03-3416-0181
Homepage URL https://www.jsfc.jp/treatment/index.html
Email wada-s@ncchd.go.jp

Sponsor
Institute Japanese Society of Fetal Cardiology
Institute
Department

Funding Source
Organization National Center for Child Health and Development
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The Japan Society of Fetal Therapy
Japanese Society of Pediatric Cardiology and Cardiac Surgery
Name of secondary funder(s) None

IRB Contact (For public release)
Organization IRB in National Center for Child Health and Development
Address 2-10-1 Okura, Setagaya, Tokyo 157-8535, Japan
Tel 03-3416-0181
Email rinken@ncchd.go.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 国立成育医療研究センター(東京都)
National Center for Child Health and Development (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 08 Day

Related information
URL releasing protocol https://www.jsfc.jp/treatment/index.html
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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 25 Day
Date of IRB
2015 Year 03 Month 06 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 06 Month 30 Day
Date analysis concluded
2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 05 Month 04 Day
Last modified on
2019 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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