UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019413 |
|---|---|
| Receipt number | R000022016 |
| Scientific Title | Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis |
| Date of disclosure of the study information | 2015/10/19 |
| Last modified on | 2019/04/23 12:25:29 |
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Basic information
Public title
Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Acronym
Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Scientific Title
Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Scientific Title:Acronym
Clinical Evaluation of Prosthetic Valve in Patients with Aortic Stenosis
Region
| Japan |
Condition
Condition
Aortic Stenosis
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aortic valve replacement (AVR) ia a most common therapy for aortic stenosis (AS). It is a major problem that Japanese people have smaller annuluses than European. Because their annuluses is small, conventional AVR cannot release left ventricular outlet tract obstruction (LVOTO) and improve left ventricular function. Therefore, root enlarging or placing the valve partly in a supraannular position is often performed, however it is difficult in some cases.
Patient-prosthesis mismatch(PPM) is defined that after valve replacement operation the effective orifice area (EOA) of prosthetic valve is smaller than the native valve. According to this definition, in the case that no prohstetic
valve has same orifice area to the normal aortic valve, PPM occurs in all patients after operations. However, PPM is not intercorrelate with the size of prosthetic valve but also with body surface area(BSA), therefore the effective orifice area index(EOAI), that is defined as EOA of the prosthetic valve devided by BSA, are used in evaluating the PPM. We have examined how the PPM effect clinically in AVR, however it is not clear.
In this study, We examine whether ATS 16AP that is the smallest prosthetic valve in the world avoids the PPM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative cardiac function
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
a
Key exclusion criteria
a
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikatsu Saiki |
Organization
Graduate school of medicine
Division name
Division of Cardiovascularsurgery
Zip code
Address
Seiryo1-1,Aoba ward, Sendai city
TEL
022-717-7222
yoshisaiki@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ko Sakatsume |
Organization
Graduate school of medicine
Division name
Division of Cardiovascularsurgery
Zip code
Address
Seiryo1-1,Aoba ward, Sendai city
TEL
022-717-7222
Homepage URL
kosakatsume@gmail.com
Sponsor or person
Institute
Division of Cardiovascular Surgery, TOHOKU University Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2015 | Year | 10 | Month | 19 | 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 | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter trial in Tohoku University Hospital and the other hospitals. We examine the cases of AVR performed from January 2008 to August 2015 with ATS16AP. We collect and evaluate the data related to the prognosis and the results of UCG.
Management information
Registered date
| 2015 | Year | 10 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022016
