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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024296
Receipt No. R000027948
Scientific Title Study on the simplification of the artificial chordae reconstruction for mitral regurgitation
Date of disclosure of the study information 2016/10/04
Last modified on 2016/10/04

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Basic information
Public title Study on the simplification of the artificial chordae reconstruction for mitral regurgitation
Acronym Study on the artificial chordae reconstruction for mitral regurgitation
Scientific Title Study on the simplification of the artificial chordae reconstruction for mitral regurgitation
Scientific Title:Acronym Study on the artificial chordae reconstruction for mitral regurgitation
Region
Japan

Condition
Condition Mitral regurgitation
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Artificial chordae reconstruction is one of the key procedures for mitral valve surgery to increase the success rate of mitral valve repair. Various techniques of chordae reconstruction using Gore-Tex suture have already been reported. However, uncertain reproducibility and procedural complexity of these techniques are still concerns. We have developed a suitable device for artificial chordae reconstruction. The present study was designed to evaluate the efficacy of this device in the human mitral valve repair.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The degree of mitral regurgitation
Key secondary outcomes Left ventricular function
The presence of left ventricular outflow tract obstruction
Left atrial volume
Left ventricular inflow velocity waveform

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo elective mitral valve repair for degenerative lesion of the anterior leaflet of mitral valve.
Key exclusion criteria Patients who undergo emergent mitral valve repair for active infective endocarditis or mitral regurgitation due to acute myocardial infarction.
Patients with a history of mitral valve surgery.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keij Oi
Organization Tokyo Medical and Dental University
Division name Cardiovascular Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku
TEL 03-5803-5270
Email keijioi.cvsg@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keij Oi
Organization Tokyo Medical and Dental University
Division name Cardiovascular Surgery
Zip code
Address 1-5-45, Yushima, Bunkyo-ku
TEL 03-5803-5270
Homepage URL
Email keijioi.cvsg@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Cardiovascular Surgery
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Cardiovascular Surgery
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
Address
Tel
Email

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
2016 Year 10 Month 04 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The following information is obtained from the medical records of the study subjects.
General clinical results
Surgery information
Echocardiography
Long-term follow-up results

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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