UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Okinawa Severe Aortic Stenosis Registry
Title of the study (Brief title)	Okinawa Severe Aortic Stenosis Registry
Region	Japan

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

Objectives
Narrative objectives1	Elderly people in Okinawa have longevity. The arteriosclerotic severe aortic stenosis, which is often found in the elderly increases gradually. The elderly people have high frailty due to the complicated diseases other than valvular disease. The many cases of high-risk and inoperable cases of aortic valve replacement surgery. The new methods of treatment for such cases developed. We will assess the effectiveness of each treatment method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary events after participation: All cause of death, sudden death cardiac death, surgical aortic valve replacement, transcatheter aortic valve replacement, balloon aortic valvuloplasty, admission by heart failure and any other reasons.
Key secondary outcomes	The echocardiographic findings, subjective complaint and blood test findings in every half years after participation.

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 severe aortic stenosis diagnosed at Okinawa main hospital
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	Masashi Iwabuchi
Organization	Graduate School of Medicine, University of the Ryukyus
Division name	Department of Cardiovascular Medicine, Nephrology and Neurology
Address	207 Uehara, Nihihara-cho, Okinawa, Japan
TEL	098-895-1150
Email	msiwabuchi@yahoo.co.jp

Public contact
Name of contact person	Masashi Iwabuchi
Organization	Graduate School of Medicine, University of the Ryukyus
Division name	Department of Cardiovascular Medicine, Nephrology and Neurology
Address	207 Uehara, Nihihara-cho, Okinawa, Japan
TEL	098-895-1150
Homepage URL
Email	msiwabuchi@yahoo.co.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	University of the Ryukyus
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 10 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 18 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observation items: Echocardiographic findings every six months since registration, general blood tests, BNP or ProBNP and subjective symptoms, Frailty related items were registered until 3 years after registration. Survey until 3 years after registering existence of major events. (Major events: All cause of death, sudden death, cardiac death, surgical aortic valve replacement, transcatheter aortic valve replacement, aortic valve balloon valvuloplasty, hospitalization due to heart failure, hospitalization for any reason)

Management information
Registered date	2017 Year 10 Month 03 Day
Last modified on	2017 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033561