UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024296 |
|---|---|
| Receipt number | 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 20:15:55 |
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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
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
keijioi.cvsg@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Cardiovascular Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027948
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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