UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045637 |
|---|---|
| Receipt number | R000052102 |
| Scientific Title | Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results. |
| Date of disclosure of the study information | 2021/10/04 |
| Last modified on | 2022/12/06 10:05:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Acronym
Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Scientific Title
Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Scientific Title:Acronym
Surgical Managements for Mitral valve regurgitation in Infancy: Its Mid-term Results.
Region
| Japan |
Condition
Condition
mitral valve regurgitation
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We reviewed early and mid-term outcome of the patients underwent mitral valve surgery for moderate or more mitral valve regurgitation in less than 12 months old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Death at last follow-up.
Key secondary outcomes
Reoperation, mitral valve replacement and moderate or more mitral 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
| 12 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients less than 12 months old who underwent mitral valve surgery for moderate or more mitral valve regurgitation at Hyogo prefectural Amagasaki general medical center from October 2005 to March 2019.
Key exclusion criteria
Patients of 1 year old or older. Patients with atrioventricular septal defect, functional single ventricle, atrioventricular and/or ventriculoarterial discordance, and dominance of atrioventricular valve stenosis.
Target sample size
18
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
| 2021 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Already accepted and published by the journal
Publication of results
Published
Result
URL related to results and publications
Already accepted and published by the journal
Number of participants that the trial has enrolled
18
Results
There was no operative mortality, one case of late death. The median follow-up period was 7 years and 9 months. Reoperation was performed in three patients. Fifteen patients had at most mild MR at the last follow-up. A transmitral mean pressure gradient of over 5 mmHg was observed in three cases. Postoperative mitral annular diameter increased within normal range. Survival and reoperation-free rates at 5 and 10 years were 94.4% and 83.0%, respectively.
Results date posted
| 2022 | Year | 10 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively reviewed 18 patients (aged< 12 months old) undergoing mitral valve surgery for mitral regurgitation. The patients had ten acquired and eight congenital valve lesions as follows: torn chordae (n = 6), leaflet prolapse (n = 4), posterior leaflet hypoplasia (n = 3), anterior leaflet cleft (n = 2), infective endocarditis (n = 1), papillary muscle rupture (n = 1), and hammock valve (n = 1).
Participant flow
All patients already underwent operations, and follow-up data was used.
Adverse events
No adverse events occurred due to this study.
Outcome measures
death, reoperation, MR moderate/severe-free rate.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2005 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The medical records of all 18 patients less than 12 months old who underwent mitral valve surgery for moderate or more mitral valve regurgitation at Hyogo prefectural Amagasaki general medical center between October 2005 and March 2019 were retrospectively reviewed about early and mid-term outcomes.
Management information
Registered date
| 2021 | Year | 10 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052102
