UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028160 |
|---|---|
| Receipt number | R000032229 |
| Scientific Title | Robotic mitral valve repair using da Vinci Surgical System for mitral regurgitation: A safety and feasibility study |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/01/20 15:31:09 |
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Basic information
Public title
Robotic mitral valve repair using da Vinci Surgical System for mitral regurgitation: A safety and feasibility study
Acronym
Robotic mitral valve repair: A safety and feasibility study
Scientific Title
Robotic mitral valve repair using da Vinci Surgical System for mitral regurgitation: A safety and feasibility study
Scientific Title:Acronym
Robotic mitral valve repair: A safety and feasibility study
Region
| Japan |
Condition
Condition
mitral regurgitation (MR)
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mitral valve repair (MVP) under full sternotomy is a gold standard procedure for MR and gives good outcomes, but it takes some time to rehabilitate because of sternotomy. Therefore, minimally invesive MVPs have been performed widely. This time, to pursue less invasiveness, da Vinci will be introcuced and robotic MVP will proceed and the safety will be assessed.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MR after 2 weeks postoperatively
MR after 3 months postoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
da Vinci will be rolled in after cardiopulmonary bypass and mitral valve plasy will be done with da Vinci. After mitral valve plasy is completed, da Vinci will be rolled out.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) MR is dianosed.
2) MR which is a operative indication
(a) acute MR with symptum
(b) chronic MR with NYHA II-IV and LVEF > 30%
(c) chronic MR without symptum and LVEF ranging from 30% and 60% or LVDs > 40mm
3) obtained infromed consent
4) the age between 20 years and 80 years
Key exclusion criteria
1) a patient who has a cancer
2) a patient with hemodialysis
3) a patient who participates in other clinical studies
4) a patient who had myocardial infarction within 30 days
5) a patient who had stroke within 180 days
6) a patient who had coronary stent within 30 days
7) a patient who has other procedures than mitral valve, except Maze or PV isolation
8) LVEF > 30%
9) BMI > 35kg/m2
10) active endocarditis
11) a patient who had previously sternotomy or right thoracotomy
12) a patient who had previously radiation therpay on his chest
13) a patient whom the principal investigator considers inappropriate for this clinical study
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Osaka University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
2-2-E1 yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3154
sawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Yoshikawa |
Organization
Osaka University Hospital
Division name
Cardiovascular Surgery
Zip code
Address
2-2-E1 yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3154
Homepage URL
http://www2.med.osaka-u.ac.jp/surg1/
yoshikawa@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Ministry of Education
Institute
Department
Personal name
Funding Source
Organization
Osaka University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 08 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032229
