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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019716
Receipt No. R000022766
Scientific Title Study for correlation between VO2 and survival ratio in elder patients with severe aortic stenosis after trance catheter aortic valve replacement.(Vista study).
Date of disclosure of the study information 2015/11/10
Last modified on 2017/12/25

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Basic information
Public title Study for correlation between VO2 and survival ratio in elder patients with severe aortic stenosis after trance catheter aortic valve replacement.(Vista study).
Acronym Vista study
Scientific Title Study for correlation between VO2 and survival ratio in elder patients with severe aortic stenosis after trance catheter aortic valve replacement.(Vista study).
Scientific Title:Acronym Vista study
Region
Japan

Condition
Condition Aortic Stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Correlation between peak VO2 and survival rate in patients with aortic stenosis after TAVR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between peakVO2 and survival rate of 12 month after ATVR
Key secondary outcomes Correlation among PeakVO2,VO2 at AT,PeakVO2/HR,minimum VE/VO2,VE vs VCO2 slope,delta VO2 WR,tau,peak/mean PG,max Velocity,AVA,AR,PVL,volume/grade,E/A,DcT,E/E dash and survival rate,re hospitalization, MACCE.

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 Patients with aortic stenosis after TAVR
Key exclusion criteria Patients who can not be obtained the agreement form
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Murata Makoto
Organization Gunma Prefectual Cardiovascular Center
Division name Division of Cardiology
Zip code
Address 3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL 027-269-7455
Email yarukimanmann2000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Murata Makoto
Organization Gunma prefectual cardiovascular center
Division name Division of Cardiology
Zip code
Address 3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL 027-269-7455
Homepage URL
Email yarukimanmann2000@yahoo.co.jp

Sponsor
Institute Gunma prefectual cardiovascular center
Institute
Department

Funding Source
Organization Gunma prefectual cardiovascular center
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
Email

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 群馬県立心臓血管センター
Gunma prefectual cardiovascular center

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 10 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 11 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 11 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 01 Month 31 Day
Date analysis concluded
2018 Year 01 Month 31 Day

Other
Other related information We peforme Cardiopulmonary exercise test after TAVR to observe the survival rate after one year.

Management information
Registered date
2015 Year 11 Month 09 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022766

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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