UMIN-CTR Clinical Trial

Basic information
Public title	Treatment and prognosis of heart valve registry
Acronym	Heart valve registry
Scientific Title	Treatment and prognosis of heart valve registry
Scientific Title:Acronym	Heart valve registry
Region	Japan

Condition
Condition	aortic stenosis/mitral regurgitation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. We reveal the natural history about occurrence of cardiovascular events, the pace of the illness and that factor of the patients of aortic stenosis/mitral regurgitation. And we reveal the proper timing to offer invasive procedure. 2. We record detail of contents of procedure (surgical operation, Transcatheter Aortic Valve Implantation and Mitral Clip) and follow-up, we reveal the incidence of adverse events related to procedure or surgical result. In addition, we reveal factors affecting the incidence of adverse events and the prognosis after procedure.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	During follow the natural history: 1. Mortality (all cause mortality, cardiovascular death, non-cardiovascular death) 2. Invasive procedure (surgical aortic valve replacement, mitral valve replacement, Transcatheter Aortic Valve Implantation, mitral valvuloplasty and Mitral Clip) 3. Admission of heart failure 4. Progression of heart valve by transthoracic echocardiography (increase of max velocity and pressure gradient, decrease of aortic valve area, and exacerbation of mitral regurgitation) After the invasive procedure: 1. Perioperative period: in-hospital death, complication (myocardial infarction, cardiac tamponade, vascular accident, auriculoventricular block for needing pacemaker, cerebral infarction, bleeding for needing blood transfusion) 2. Follow-up 1year, 2year, 3year, 4year, 5year after procedure: presence or absence of admission of heart failure, presence or absence of the death (cardiovascular death, non-cardiovascular death)
Key secondary outcomes

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 undergo transthoracic echocardiography at Keio University hospital and satisfy the following any items. A. A patient who has more than moderate aortic valvular stenosis B. A patient who has more than moderate mitral regurgitation
Key exclusion criteria	The patients who are under the 20 years old or who are found unfit to be respondent to a survey by physician-in-charge
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Hayashida
Organization	Keio University Hospital
Division name	Department of cardiology
Zip code	160-8582
Address	35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Email	k-hayashida@umin.ac.jp

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Yoshijima
Organization	Keio University Hospital
Division name	Department of cardiology
Zip code	160-8582
Address	35, Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	nobuhiro_yossi@yahoo.co.jp

Sponsor
Institute	OCEAN-SHD organization
Institute
Department

Funding Source
Organization	Edwards Lifesciences, Medtronic, Boston Scientific, and Daiichi-Sankyo Company.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee of Keio University School of Medicine
Address	Shinjyuku-ku Shinanomachi 35, Tokyo
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.jp

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 17 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	2013 Year 04 Month 22 Day
Date of IRB	2013 Year 04 Month 22 Day
Anticipated trial start date	2013 Year 04 Month 22 Day
Last follow-up date	2028 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: An observational study Way for subscription: Explain the content of this research verbally using an explanatory document and obtain consent to participate in this research. We present a information of study implementation and Opt-out document about this clinical research to Keio University Hospital Website, Clinical Research Promotion Center Website and Cardiovascular Internal Medicine Website, and we release the content of this study implementation. We give an Opt-out document to such patients needs in any way. The cases of the patient who refuse registration, we indicate so on the clinical record and we don't collect information. Term of registration: 5-years

Management information
Registered date	2016 Year 08 Month 17 Day
Last modified on	2020 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027188