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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023705
Receipt No. R000027271
Scientific Title Transcatheter aortic valve implantation for aortic stenosis registry
Date of disclosure of the study information 2016/08/21
Last modified on 2018/12/14

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Basic information
Public title Transcatheter aortic valve implantation for aortic stenosis registry
Acronym AS-TAVI registry
Scientific Title Transcatheter aortic valve implantation for aortic stenosis registry
Scientific Title:Acronym AS-TAVI registry
Region
Japan

Condition
Condition Aortic stenosis
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This registry was initiated to observe and document the course of aortic stenosis, that was considered TAVI as a treatment. Especially for the cases treated by TAVI, we focus on procedural results and post-procedural outcome of TAVI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cumulative survival rate after TAVI
Key secondary outcomes Cardiac death after TAVI
Re-admission for heart failure after TAVI
Cerebrovascular event after TAVI
Improvemtnt of NYHA classification and mean aortic gradient after TAVI

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 The patients who have aortic stenosis for which TAVI was considered in Keio University hospital.
Key exclusion criteria The patients who are under 20 years old or who are deemed to be unfit as subjects of our survey.
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Hayashida
Organization Keio University Hospital
Division name Cardiology
Zip code
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email k-hayashida@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Hayashida
Organization Keio University Hospital
Division name Cardiology
Zip code
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email k-hayashida@umin.ac.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Toyohashi Heart Center
Teikyo University Hospital
Shin-tokyo Hospital
Kokura Memorial Hospital
Sendai Kousei Hospital
Shonan Kamakura Hospital
Saiseikai Yokohamashi Tobu Hospital
Ogaki Municipal Hospital
Kishiwada Tokushukai Hospital
Tokyo Bay Urayasu/Ichikawa Medical Center
Osaka City University Hospital
Toyama University Hospital
Nagoya Heart Center
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

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 21 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective, observational study, and will last about 6 years.

Management information
Registered date
2016 Year 08 Month 20 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027271

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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