UMIN-CTR Clinical Trial

Basic information
Public title	Safety and feasibility study of aortic valve reconstruction with autologous pericardium.
Acronym	Study of arotic valve reconstruction with autologous pericardium.
Scientific Title	Safety and feasibility study of aortic valve reconstruction with autologous pericardium.
Scientific Title:Acronym	Study of arotic valve reconstruction with autologous pericardium.
Region	Japan

Condition
Condition	Aortic valve steosis, aortic valve regurgitation
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To access the safety and feasibility of the aortic valve reconstruction with autologous pericardium
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Reoperation free rate 3 years after operation.
Key secondary outcomes	Aortic valve malfunction free rate for 3 year after operation.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Aortic valve reconstruction with 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with aortic stenosis or aortic regurgitation with indication of aortic valve replacement. 2) indicated for conventional cardiopulmonary bypass. 3) with informed consent.
Key exclusion criteria	1) Patients who needs concomitant aditional mitral valve operation or aortic surgery. 2) with severe aortic calcification. 3) with hemodyalysis 4) patients who deemed inappropriate for aortic valve repair.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shibata Toshihiko
Organization	Osaka City University Graduate School of Medicine
Division name	Dept. of Cardiovascular Surgery
Zip code
Address	1-4-3 Asahimachi, Abenoku, Osaka
TEL	06-6645-3980
Email	shibata-cvs@zeus.eonet.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Shibata Toshihiko
Organization	Osaka City University Graduate School of Medicine
Division name	Dept. of Cardiovascular Surgery
Zip code
Address	1-4-3 Asahimachi, Abenoku, Osaka
TEL	06-6645-3980
Homepage URL
Email	shibata-cvs@zeus.eonet.ne.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka City University Graduate School of Medicine, Dept. of Cardiovascular Surgery
Organization
Division
Category of Funding Organization	Self funding
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	Osaka City University Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 20 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	Completed
Date of protocol fixation	2015 Year 03 Month 03 Day
Date of IRB	2016 Year 03 Month 03 Day
Anticipated trial start date	2016 Year 02 Month 16 Day
Last follow-up date	2020 Year 03 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	2016 Year 02 Month 15 Day
Last modified on	2020 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019546