UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001641 |
|---|---|
| Receipt number | R000001973 |
| Scientific Title | Hemodynamic performance evaluation of SJM-Regent mechanical valve by Doppler echocardiography |
| Date of disclosure of the study information | 2009/01/16 |
| Last modified on | 2011/07/16 09:13:16 |
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Basic information
Public title
Hemodynamic performance evaluation of SJM-Regent mechanical valve by Doppler echocardiography
Acronym
Hemodynamic performance evaluation of SJM-Regent mechanical valve by Doppler echocardiography
Scientific Title
Hemodynamic performance evaluation of SJM-Regent mechanical valve by Doppler echocardiography
Scientific Title:Acronym
Hemodynamic performance evaluation of SJM-Regent mechanical valve by Doppler echocardiography
Region
| Japan |
Condition
Condition
Patients of valve replacement using SJM-Regent mechanical valve
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research has aimed to evaluate valve function of SJM-regent mechanical valve by Doppler echocardiography.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
effective orifice area index
Key secondary outcomes
peak pressure gradient, meanpressure gradient, ejection fraction, effective orifice area
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
aortic valve replacement' cases using SJM Regent
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
valve disease
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Sezai |
Organization
Nihon University Itabashi Hosipial
Division name
Department of Cardiovascular Surgery
Zip code
Address
30-1 Oyagichi kami-machi, Itabashi-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nihon University school of medicine
Division name
Department of Cardiovascular Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Nihon University Itabashi Hosipial
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2009 | Year | 01 | Month | 16 | 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
| 2004 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 16 | Day |
Last modified on
| 2011 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001973
