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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036671
Receipt No. R000041768
Scientific Title Tokai Valve Registry
Date of disclosure of the study information 2019/05/08
Last modified on 2019/05/08

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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
Email 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
Email y-ohno@umin.ac.jp

Sponsor
Institute Tokai University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041768

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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