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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020423
Receipt No. R000023585
Scientific Title The OCEAN-TAVI (Optimised transCathEter vAlvular interveNtion) registry
Date of disclosure of the study information 2016/01/04
Last modified on 2020/06/15

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Basic information
Public title The OCEAN-TAVI (Optimised transCathEter vAlvular interveNtion) registry
Acronym The OCEAN-TAVI registry
Scientific Title The OCEAN-TAVI (Optimised transCathEter vAlvular interveNtion) registry
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 This registry was initiated to observe and document procedural results and post-procedural outcome of TAVI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes death, cardiovascular death, non-cardiac death
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the presence of degenerative AS with a mean gradient > 40 mmHg or a jet velocity greater than 4.0 m/s or an aortic valve area < 1.0 cm2 (or an effective orifice area Index < 0.6 cm2/m2). Patients for whom TAVI was deemed to be the best treatment option were selected based on the clinical consensus of a multidisciplinary team consisting of cardiac surgeons, interventional cardiologists, anesthetists, and imaging specialists.
Key exclusion criteria The patients who are not suitable for TAVI decided by a multidisciplinary team.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hayashida
Organization Keio University School of Medicine
Division name Cardiology
Zip code
Address 35 Shinanomachi Sinjyuku-ku Tokyo Japan
TEL 03-3353-1211
Email k-hayashida@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hayashida
Organization Keio University School of Medicine
Division name Cardiology
Zip code
Address 35 Shinanomachi Sinjyuku-ku Tokyo Japan
TEL 03-3353-1211
Homepage URL
Email k-hayashida@umin.ac.jp

Sponsor
Institute OCEAN organization
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Edwards Lifescience
Medtronic
Daiichi-Sankyo Company, Limited
Boston Scientific
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
Address
Tel
Email

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
Anticipated trial start date
2014 Year 03 Month 14 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 Involving 20 Japanese centers until Jan 2020

Management information
Registered date
2016 Year 01 Month 04 Day
Last modified on
2020 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023585


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