UMIN-CTR Clinical Trial

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

aortic stenosis/mitral regurgitation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

OCEAN-SHD organization

Institute

Department

Personal name

Organization

Edwards Lifesciences, Medtronic, Boston Scientific, and Daiichi-Sankyo Company.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

08

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2016

Year

08

Month

17

Day

Last modified on

2020

Year

08

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027188