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
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
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
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 |
