UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036649 |
|---|---|
| Receipt number | 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 | 2022/05/05 23:23:34 |
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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 | Obstetrics 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
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
wada-s@ncchd.go.jp
Sponsor or person
Institute
Japanese Society of Fetal Cardiology
Institute
Department
Personal name
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
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
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 04 | Day |
Last modified on
| 2022 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041750
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
