UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2013 Year 10 Month 01 Day
Date of IRB	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2020 Year 02 Month 22 Day
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	2020 Year 02 Month 22 Day

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