UMIN-CTR Clinical Trial

Basic information
Public title	Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Acronym	Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Scientific Title	Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Scientific Title:Acronym	Registry of Severe Aortic Stenosis in Sendai Kousei Hospital
Region	Japan

Condition
Condition	Severe aortic stenosis
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Observational study, registry of severe aortic stenosis in Sendai Kousei Hospital
Basic objectives2	Others
Basic objectives -Others	To enroll all patient of severe aortic stenosis in Sendai Kousei Hospital and to investigate their clinical background, outcome in interventional therapy such as surgery or transcatheter therapy, and outcome in medical therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival at 1 year
Key secondary outcomes	30days cardiovascular death in interventional therapy cohort 30days major adverse event in interventional therapy cohort Major adverse event at 1 year

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	Severe aortic stenosis defined as maximal aortic valve velocity greater than 4.0 m/s, systolic mean gradient greater than 40mmHg, or aortic valve area 1.0cm2 in echocardiography
Key exclusion criteria	Aortic prosthetic valve
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Middle name Last name Norio Tada
Organization	Sendai Kousei Hospital
Division name	Cardiovascular center
Zip code
Address	4-15 Hirosemachi Aoba Sendai, Miyagi
TEL	022-222-6181
Email	noriotada@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Norio Tada
Organization	Sendai Kousei Hospital
Division name	Cardiovascular center
Zip code
Address	4-15 Hirosemachi Aoba Sendai, Miyagi
TEL	022-222-6181
Homepage URL
Email	noriotada@hotmail.com

Sponsor
Institute	Sendai Kousei Hospital
Institute
Department

Funding Source
Organization	Sendai Kousei Hospital
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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 01 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	Open public recruiting
Date of protocol fixation	2014 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry	2020 Year 05 Month 31 Day
Date trial data considered complete	2020 Year 05 Month 31 Day
Date analysis concluded	2021 Year 05 Month 31 Day

Other
Other related information	This is an observational study.

Management information
Registered date	2014 Year 05 Month 24 Day
Last modified on	2014 Year 07 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016366

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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