UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040413
Receipt number R000046115
Scientific Title International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)
Date of disclosure of the study information 2020/05/31
Last modified on 2022/05/25 10:29:43

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Basic information

Public title

International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)

Acronym

International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)

Scientific Title

International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)

Scientific Title:Acronym

International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)

Region

Japan Europe


Condition

Condition

aortic stenosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is that the long term outcomes (> 10 years) after TAVI. The other purpose of this study is that to establish predictive model for early clinical event.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

long term (> 10 years) outcomes (mortality, durability of THV and late cardiovascular event other than mortality)

Key secondary outcomes

establish predictive model for early clinical event (stroke, bleeding etc)


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

The patients who underwent or undergo trans catheter aortic valve implantation for aortic stenosis.

Key exclusion criteria

none

Target sample size

4500


Research contact person

Name of lead principal investigator

1st name Shigeru
Middle name
Last name Saito

Organization

Shonan Kamakura general Hospital

Division name

Department of Cardiology

Zip code

247-8533

Address

Okamoto 1370-1, Kamakura, Japan

TEL

0467-46-1717

Email

transradial@kamakuraheart.org


Public contact

Name of contact person

1st name Noriaki
Middle name
Last name Moriyama

Organization

Shonan Kamakura general Hospital

Division name

Department of Cardiology

Zip code

247-8533

Address

Okamoto 1370-1, Kamakura, Japan

TEL

0467-46-1717

Homepage URL


Email

e2718nm@gmail.com


Sponsor or person

Institute

Shonan Kamakura General Hospital

Institute

Department

Personal name



Funding Source

Organization

Shonan Kamakura General Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Tokushukai Group Ethics Committee

Address

Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com


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

2020 Year 05 Month 31 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

2020 Year 06 Month 04 Day

Date of IRB

2020 Year 06 Month 24 Day

Anticipated trial start date

2020 Year 06 Month 05 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 05 Month 15 Day

Last modified on

2022 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046115


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name