UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026020
Receipt number R000029911
Scientific Title Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study
Date of disclosure of the study information 2017/03/31
Last modified on 2022/05/29 13:05:48

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Basic information

Public title

Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study

Acronym

Stentless mitral valve replacement: pilot study

Scientific Title

Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study

Scientific Title:Acronym

Stentless mitral valve replacement: pilot study

Region

Japan


Condition

Condition

mitral valve stenosis, mitral valve stenosis and regurgitation

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the safety and efficacy of the autologous pericardial stentless mitral valve replacement. This study is pilot study for future multi-institutional study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Presence of mitral valve regurgitation 2 weeks after surgery

Key secondary outcomes

Presence of adverse event wiyhin 12 months after surgery


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Autologous pericardial stentless mitral valve replacement

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

16 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.severe mitral stenosis, or mitral stenosis and regurgitation, no indication of valve plasty.
2. no indication for catheter intervention treatment
3. mitral valve stenosis: post mitral valve replacement using bioprosthetic valve.
4. mitral valve stenosis: post mitral valve replacement using mechanical valve.
5. Congenital mitral valve stenosis.

Key exclusion criteria

1. Malignancy
2. Hemodialysis
3. Included other clinical study
4. Myocardial infarction within 6 months
5. Strole within 6 months
6. Coronary intervention within 1 months
7. Indication for other cardiac diseases (tricuspid, atrial fibrillation excluded)
8. sever left ventricular dysfunction
9. Conventional treatment is expected to be the best.

Target sample size

1


Research contact person

Name of lead principal investigator

1st name Hitoshi
Middle name
Last name Yaku

Organization

Kyoto Prefectural University of Medicine

Division name

Cardiovascular surgery

Zip code

6028566

Address

465 Kajiicho Kamigyo Kyoto

TEL

0752515752

Email

yakuh@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Numata

Organization

Kyoto Prefectural University of Medicine

Division name

Cardiovascular surgery

Zip code

6028566

Address

465 Kajiicho Kamigyo Kyoto

TEL

0752515752

Homepage URL


Email

snumat@yahoo.co.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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

Ethical Review Board, Kyoto Prefectural University of Medicine.

Address

465 Kajiicho Kamigyo Kyoto JAPAN

Tel

0752515337

Email

kpu@bvits.com


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

京都府立医科大学付属病院


Other administrative information

Date of disclosure of the study information

2017 Year 03 Month 31 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

0

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 02 Month 19 Day

Date of IRB

2018 Year 03 Month 15 Day

Anticipated trial start date

2017 Year 03 Month 31 Day

Last follow-up date

2021 Year 12 Month 31 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 02 Month 06 Day

Last modified on

2022 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029911


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name