UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients
Title of the study (Brief title)	Research of Safety and efficacy of the decelllerized human heart valve after the trasplantation to congenital heart disease patients
Region	Japan

Condition
Condition	congenital heart disease with pulmonary valve insuffucency
Classification by specialty	Vascular surgery Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of the decellulerized heart valve after transplantation for pulmonary valve insufficiency congenital heart disease patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the safety and durability of the transplanted decellularized heart valve 3 month after the transplantation
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	pulmonary valve transplantation with decellularized heart valve for pulmonary valve insufficiency congenital heart disease patients
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	Indication for pulmonary valve replacement according to current medical guidelines in congenital heart disease Informed consent of parents (both) or patients, assent of patients (<18 years)
Key exclusion criteria	The patient has not provided Study informed consent. The patient has active endocarditis (within the last 3 month). The patient has an abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyreoidism).
Target sample size	7

Research contact person
Name of lead principal investigator	Yoshiki Sawa
Organization	Osaka University hospital
Division name	Cardiovascular surgery
Address	2-15 Yamadaoka,suita,Osaka
TEL	06-6879-3154
Email	sawa@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person	Hideto Ozawa
Organization	Osaka University hospital
Division name	Cardiovascular surgery
Address	2-15 Yamadaoka,suita,Osaka
TEL	06-6879-3154
Homepage URL
Email	h-ozawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 07 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021303