UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020423
Receipt number R000023585
Scientific Title The OCEAN-TAVI registry (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation)
Date of disclosure of the study information 2016/01/04
Last modified on 2023/07/11 21:44:23

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Basic information

Public title

The OCEAN-TAVI registry (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation)

Acronym

The OCEAN-TAVI registry

Scientific Title

The OCEAN-TAVI registry (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation)

Scientific Title:Acronym

The OCEAN-TAVI registry

Region

Japan


Condition

Condition

Aortic stenosis

Classification by specialty

Cardiology Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate procedural characteristics, adverse events, and predictors for adverse events and prognosis after procedure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

death, cardiovascular death, non-cardiac death

Key secondary outcomes

Additional invasive procedure (Valve repair/replacement, Vascular plug, PCI, PPI, etc.) Readmission event (heart failure, pneumonia, bleeding event, etc.) Heart valve deterioration and thrombosis formation evaluated by transthoracic echocardiography and/or computed tomography


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 were deemed to be good candidates for TAVI based on discussion of a local heart team from October 2013.

Key exclusion criteria

Patients who were deemed to be unsuitable for TAVI based on discussion of a local heart team.

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Kentrao
Middle name
Last name Hayashida

Organization

Keio University School of Medicine

Division name

Department of cardiology

Zip code

160-8582

Address

35, Shinanomachi, Shinjyuku-ku, 160-8582, Tokyo, Japan

TEL

03-3353-1211

Email

k-hayashida@umin.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Hayashida

Organization

Keio University School of Medicine

Division name

Department of cardiology

Zip code

160-8582

Address

35, Shinanomachi, Shinjyuku-ku, 160-8582, Tokyo, Japan

TEL

03-3353-1211

Homepage URL


Email

k-hayashida@umin.ac.jp


Sponsor or person

Institute

OCEAN-SHD organization

Institute

Department

Personal name



Funding Source

Organization

Edwards Lifescience
Medtronic
Daiichi-Sankyo Company
Boston Scientific
Abbott vascular

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 of Medicine

Address

35 Shinanomachi Sinjyuku-ku, 160-8582, Tokyo, Japan

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 01 Month 04 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

Enrolling by invitation

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB

2015 Year 02 Month 12 Day

Anticipated trial start date

2015 Year 02 Month 12 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

From July 2022, 22 institutions in Japan are participating in this registry.


Management information

Registered date

2016 Year 01 Month 04 Day

Last modified on

2023 Year 07 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023585


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name