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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026020
Receipt No. 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 2017/02/06

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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
Middle name
Last name Hitoshi Yaku
Organization Kyoto Prefectural University of Medicine
Division name Cardiovascular surgery
Zip code
Address 465 Kajiicho Kamigyo Kyoto
TEL 0752515752
Email yakuh@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Numata
Organization Kyoto Prefectural University of Medicine
Division name Cardiovascular surgery
Zip code
Address 465 Kajiicho Kamigyo Kyoto
TEL 0752515752
Homepage URL
Email snumat@yahoo.co.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
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 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
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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 31 Day
Last follow-up date
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
2017 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.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


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