UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035804 |
|---|---|
| Receipt number | 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 15:25:50 |
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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
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
hiromi03@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040770
