UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049925 |
|---|---|
| Receipt number | R000056612 |
| Scientific Title | Tricuspid valve repair for tricuspid valve regurgitation in pediatric patients: Its mid-term results. |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2024/06/28 10:40:45 |
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Basic information
Public title
Tricuspid valve repair for tricuspid valve regurgitation in pediatric patients: Its mid-term results.
Acronym
Tricuspid valve repair for tricuspid valve regurgitation in pediatric patients: Its mid-term results.
Scientific Title
Tricuspid valve repair for tricuspid valve regurgitation in pediatric patients: Its mid-term results.
Scientific Title:Acronym
Tricuspid valve repair for tricuspid valve regurgitation in pediatric patients: Its mid-term results.
Region
| Japan |
Condition
Condition
tricuspid valve regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We reviewed mid-term outcome of the patients underwent tricuspid valve repair for moderate or more mitral valve regurgitation in less than 18 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death at last follow-up.
Key secondary outcomes
Reoperation and moderate or more tricuspid 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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients less than 18 years old who underwent tricuspid valve repair for moderate or more tricuspid valve regurgitation at Hyogo prefectural Amagasaki general medical center from October 2005 to September 2022.
Key exclusion criteria
Patients of 18 year old or older. Patients who underwent tricuspid valve replacement. Patients whose tricuspid valve is systemic atrioventricular valve.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Toshi |
| Middle name | |
| Last name | Maeda |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Cardiovascular Surgery
Zip code
660-8550
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
TEL
+81-6-6480-7000
tmsirius825@gmail.com
Public contact
Name of contact person
| 1st name | Toshi |
| Middle name | |
| Last name | Maeda |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Cardiovascular Surgery
Zip code
660-8550
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
TEL
+81-6-6480-7000
Homepage URL
tmsirius825@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hyogo Prefectural Amagasaki General Medical Center
Address
2-17-77, Higashi-Naniwa-cho, Amagasaki, Hyogo, Japan
Tel
+81-6-6480-7000
agmc.irb@gmail.com
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
| 2022 | Year | 12 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S1058981324000134
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1058981324000134
Number of participants that the trial has enrolled
26
Results
Several reparative techniques were used. There were two cases of hospital death, and no late death occurred. During the median follow-up period of 7.8 years, reoperation was performed in one patient with pulmonary atresia with intact ventricular septum. At the last follow-up, all survivors had mild or less tricuspid valve regurgitation. Postoperative tricuspid annular diameter increased within the normal range in all patients. Survival and reoperation-free rates at both 5 and 10 years were 92.3 % and 95.8 %
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 27 | Day |
Baseline Characteristics
Their median age was 3.7 years (range, 1 month-16.2 years), and 15 were males. 23 had congenital heart diseases. Among them, 35 % of patients had tetralogy of Fallot or pulmonary atresia with ventricular septal defect (9/26), followed by ventricular septal defect (23 %, 6/26).
Participant flow
A total of 26 patients aged < 18 years who underwent tricuspid valve repair for tricuspid valve regurgitation at our institute between January 2005 and September 2022 were retrospectively reviewed.
Adverse events
none
Outcome measures
death, reoperation, tricuspid valve regurgitation >= moderate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively reviewed outcomes about tricuspid valve repair in pediatric patients from January 2005 to September 2022.
Management information
Registered date
| 2022 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056612
