UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035804
Receipt No. R000040770
Scientific Title Aortic valve reconstruction with autologous pericardium for patients with small aortic annulus
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Aortic valve reconstruction with autologous pericardium for patients with small aortic annulus
Acronym Ozaki procedure for small aortic annulus
Scientific Title Aortic valve reconstruction with autologous pericardium for patients with small aortic annulus
Scientific Title:Acronym Ozaki procedure for small aortic annulus
Region
Japan

Condition
Condition severe aortic valve disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the efficacy of Ozaki procedure for severe aortic valve disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following two primary outcomes are evaluated 3 months, 1 year and 3 years after operation; 1) freedom from postoperative prosthesis-patient mismatch rate, 2) freedom from readmission from heart failure.
Key secondary outcomes The following five echocardiographic parameters are obtained 3 months, 1 year and 3 years postoperatively: 1) peak pressure gradient (mean pressure gradient), 2) effective orifice area (EOA), 3) EF%, 4) E/A, 5) E/e'

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We will perform aortic valve resonstrcution using autologous pericardium in patients with severe aortic valve disease.
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
65 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients having indication of aortic valve replacement due to severe aortic valve stenosis or insufficiency
2) Patients having the risk of prosthetic-patient mismatch (PPM) due to small aortic annulus
Key exclusion criteria 1) Bicuspid aortic valve
2) Hemodialysis patients
3) Double or triple valve procedures
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teiji Oda
Organization Shimane University Faculty of Medicine
Division name Division of Thoracic and Cardiovascular Surgery, Department of Surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2223
Email toda@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Wada
Organization Shimane University Faculty of Medicine
Division name Division of Thoracic and Cardiovascular Surgery, Department of Surgery
Zip code
Address 89-1, Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2223
Homepage URL
Email hiromi03@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 07 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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 29 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
2019 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040770

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.