UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029911