UMIN-CTR Clinical Trial

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