UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Robotic mitral valve repair using da Vinci surgical system for mitral regurgitation: A safety and feasibility study
Title of the study (Brief title)	Robotic mitral valve repair using da Vinci surgical system for mitral regurgitation: A safety and feasibility study
Region	Japan

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

Objectives
Narrative objectives1	We do mitral valve repair with da Vinci surgical system at mitral regurgiation patients. We analyze the safety and efficacy of it.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	residual mitral regurgitation
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	In operation, after the start of cardiopulmonary bypass, the robot is connected to patient. The mitral valve repair with the assist of robot. The robot is rolled out after the mitral valve repair.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) a mitral regurgitation patient who has indiction of mitral repair 2) obtained infromed consent
Key exclusion criteria	1) a patient who had past history of open chest surgery 2) a patient who had high deformity of chest (funnel chest, scoliosis) 3) a patient who can not do separate lung ventilation because of poor pulmonary function 4) a patient whom the principal investigator considers inappropriate for this clinical study
Target sample size	3

Research contact person
Name of lead principal investigator	Youhei Ohkawa
Organization	Hokkaido Ohno Memorial Hospital
Division name	Cardiovascular Surgery
Address	1-16-1, 2-jo, Miyanosawa, Nishi-ku, Sapporo-shi, Hokkaido,Japan 063-0052
TEL	011-665-0020
Email	ohkawa@cvc-ohno.or.jp

Public contact
Name of contact person	Youhei Ohkawa
Organization	Hokkaido Ohno Memorial Hospital
Division name	Cardiovascular Surgery
Address	1-16-1, 2-jo, Miyanosawa, Nishi-ku, Sapporo-shi, Hokkaido,Japan 063-0052
TEL	011-665-0020
Homepage URL
Email	ohkawa@cvc-ohno.or.jp

Sponsor
Institute	Hokkaido Ohno Memorial Hospital
Institute
Department

Funding Source
Organization	Hokkaido Ohno Memorial Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 13 Day
Anticipated trial start date	2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 14 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035733