UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029104
Receipt number R000033288
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 2017/11/01
Last modified on 2020/01/20 15:33:02

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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 1 year 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

Historical

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

33


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 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


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 11 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

Terminated

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 11 Month 02 Day

Anticipated trial start date

2017 Year 11 Month 01 Day

Last follow-up date

2018 Year 04 Month 05 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 09 Month 12 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=R000033288


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name