UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031133
Receipt number R000035566
Scientific Title Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry
Date of disclosure of the study information 2018/03/01
Last modified on 2023/08/10 13:16:29

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Basic information

Public title

Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry

Acronym

Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry

Scientific Title

Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry

Scientific Title:Acronym

Outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis: LAPLACE-TAVI registry

Region

Japan


Condition

Condition

aortic stenosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate outcomes of transcatheter aortic valve implantation in Japanese patients with aortic stenosis

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

All-cause mortality

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who underwent transcatheter aortic valve implantation

Key exclusion criteria

patient refusal

Target sample size

7000


Research contact person

Name of lead principal investigator

1st name Ryosuke
Middle name
Last name Higuchi

Organization

Sakakibara Heart Institute

Division name

Department of Cardiology

Zip code

1830003

Address

3-16-1 Asahi-cho, Fuchu, Tokyo, Japan

TEL

042-314-3111

Email

rhiguchi@shi.heart.or.jp


Public contact

Name of contact person

1st name Ryosuke
Middle name
Last name Higuchi

Organization

Sakakibara Heart Institute

Division name

Department of Cardiology

Zip code

1830003

Address

3-16-1 Asahi-cho, Fuchu, Tokyo, Japan

TEL

042-314-3111

Homepage URL


Email

rhiguchi@shi.heart.or.jp


Sponsor or person

Institute

Sakakibara Heart Institute

Institute

Department

Personal name



Funding Source

Organization

Sakakibara Clinical Research Grant for Promotion of Sciences

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sakakibara Heart Institute

Address

Asahi-cho3-16-1, Fuchu, Tokyo

Tel

0423143111

Email

rhiguchi@shi.heart.or.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

順天堂医院、三重大学医学部付属病院、山形大学医学部附属病院、弘前大学医学部附属病院、川崎幸病院、東邦大学


Other administrative information

Date of disclosure of the study information

2018 Year 03 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

2017 Year 11 Month 18 Day

Date of IRB

2017 Year 11 Month 27 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2038 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

multi-center registry


Management information

Registered date

2018 Year 02 Month 04 Day

Last modified on

2023 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name