UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056494 |
|---|---|
| Receipt number | R000064558 |
| Scientific Title | Retrospective study to evaluation of utility of pulmonary valve reconstruction with right atrial appendage tissue in tetralogy of Fallot |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/06/09 09:54:26 |
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Basic information
Public title
Evaluation of utility of pulmonary valve reconstruction with right atrial appendage tissue in tetralogy of Fallot
Acronym
EURECAA-TOF
Scientific Title
Retrospective study to evaluation of utility of pulmonary valve reconstruction with right atrial appendage tissue in tetralogy of Fallot
Scientific Title:Acronym
EURECAA-TOF
Region
| Japan |
Condition
Condition
Tetralogy of Fallot
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the utility of pulmonary valve reconstruction with right atrial appendage tissue in tetralogy of Fallot.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time of evaluation: 2 weeks, 1 month, 6 months, 1 year, 3 years, 5 years, 10 years, 15 years postoperatively.
Assesment outcomes:freedome from moderate pulmonary insufficiency
Key secondary outcomes
Time of evaluation: 2 weeks, 1 month, 6 months, 1 year, 3 years, 5 years, 10 years, 15 years postoperatively.
Assesment outcomes: freedome from reintervention, freedome from moderate pulmonary stenosis, pulmonary artery valve pressure gradient,right ventricular function,right ventricular pressure, pulmonary artery pressure, degree of pulmonary stenosis, degree of pulmonary insufficiency, overall survival, operative complication rates, length of hospital stay and length of ICU stay etc.
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
1.Cases with a diagnosis of tetralogy of Fallot
2.Cases involving intervention on the pulmonary valve
Key exclusion criteria
1. cases with pulmonary valve annulus diameter <1/4 normal pulmonary valve annulus diameter
2. cases in which the right atrial appendage cannot be secured with a rectangle of 1.5 normal valve annulus diameter in width and normal valve annulus diameter in height
3. cases in which the main pulmonary artery trunk is absent
4. Cases deemed unsuitable at conferences
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Yoshimuar |
Organization
University of Toyama
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
9300194
Address
2630 Sugitani,Toyama,Toyama
TEL
076-434-7330
ynaoki@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Toritsuka |
Organization
University of Toyama
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
9300194
Address
2630 Sugitani,Toyama,Toyama
TEL
0764347330
Homepage URL
dtoritsuka@gmail.com
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
Ethics Review Committee on Clinical and Epidemiological Research, University of Toyama
Address
2630 Sugitani,Toyama,Toyama
Tel
076-415-8857
rinri@adm.u-toyama.ac.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | 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
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
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2045 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will retrospectively collect and compare the outcomes of pulmonary valve plasty using autologous right atrial appendage (RAA) and conventional methods performed between January 1, 2004, and December 31, 2035. Consent for participation in this study will be obtained via an opt-out method through public disclosure of research information.Regarding neopulmonary valve reconstruction with right atrial appendage implementation, consent will be obtained through the surgical consent form before the procedure.
Management information
Registered date
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064558
