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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028160
Receipt No. 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 2017/07/10

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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
Email 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/
Email yoshikawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute Ministry of Education
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032229

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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