UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036671 |
|---|---|
| Receipt number | R000041768 |
| Scientific Title | Tokai Valve Registry |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2019/05/08 07:55:41 |
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Basic information
Public title
Tokai Valve Registry
Acronym
Tokai Valve Registry
Scientific Title
Tokai Valve Registry
Scientific Title:Acronym
Tokai Valve Registry
Region
| Japan |
Condition
Condition
Valvular heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the database in order to provide optimal treatment, i.e., medical therapy, surgery, or catheter-based treatment to the patients by prospectively enrolling cardiac function, heart failure severity, and treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause mortality and hospitalization due to heart failure (30 days, 1 year, and annually to 5 years after treatment)
Key secondary outcomes
heart failure functional class, exercise capacity, cardiac function parameters
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with age of over 20
-Patients with more than moderate aortic regurgitation(vena contracta 3-6mm, effective regurgitant orifice area>0.1cm2, regurgitant volume>30ml)
-Patients with more than moderate aortic stenosis(peak velocity>3m/sec, mean pressure gradient>20mmHg)
-Patients with more than moderate mitral regurgitation(vena contracta 3-6mm, effective regurgitant orifice area>0.2cm2, regurgitant volume>30ml)
-Patients with more than moderate mitral stenosis(mitral valve area<2cm2)
-Patients with more than moderate tricuspid regurgitation(vena contracta 3-6mm)
-Patients who had sufficient informed consent and provided written informed consent
Key exclusion criteria
-Patients with age of below 20
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Ohno |
| Middle name | |
| Last name | Yohei |
Organization
Tokai University Hospital
Division name
Department of Cardiology
Zip code
2591193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463931121
y-ohno@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Ohno |
Organization
Tokai University Hospital
Division name
Department of Cardiology
Zip code
2591193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463931121
Homepage URL
y-ohno@umin.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463931121
tokai-rinsho@ml.tokai-u.jp
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 | 05 | Month | 08 | 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 | 11 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study, now still enrolling patients
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041768
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
