UMIN-CTR Clinical Trial

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
Email	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
Email	tmsirius825@gmail.com

Sponsor
Institute	Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052102