UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017201
Receipt number R000019957
Scientific Title Mitral valve surgery using stentress bioprosthesis made from autologous pericardium
Date of disclosure of the study information 2015/05/01
Last modified on 2019/11/05 17:53:06

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Basic information

Public title

Mitral valve surgery using stentress bioprosthesis made from autologous pericardium

Acronym

autologous pericardium bioprosthesis

Scientific Title

Mitral valve surgery using stentress bioprosthesis made from autologous pericardium

Scientific Title:Acronym

autologous pericardium bioprosthesis

Region

Japan


Condition

Condition

Mitral insufficiency

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify the safety and the feasibility of the mitral valve surgery using stentless bioprosthesis made from autologous pericardium.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Physical data, clinical data, Echocardiogram, symptom, harm event

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

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

mitral valve replacement using stentless bioproshtesis made from autologous pericardium

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

5 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

mitral valve insufficiency

Key exclusion criteria

no concent

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideyuki Shimizu

Organization

Keio Univ

Division name

CV surgery

Zip code


Address

Shinanomachi 35

TEL

03005031211

Email

hideyuki@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideyuki Shimizu

Organization

Keio Univ

Division name

CV surgery

Zip code


Address

Shinanomachi 35

TEL

03005031211

Homepage URL


Email

hideyuki@keio.jp


Sponsor or person

Institute

CV suregry

Institute

Department

Personal name



Funding Source

Organization

MHLW

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2015 Year 05 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

2015 Year 01 Month 01 Day

Date of IRB

2015 Year 04 Month 01 Day

Anticipated trial start date

2015 Year 05 Month 01 Day

Last follow-up date

2019 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 04 Month 21 Day

Last modified on

2019 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019957


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name