UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033216 |
|---|---|
| Receipt number | R000037795 |
| Scientific Title | CoreValve Evolut R TAV in SAV Japan Regulatory PMS |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2025/01/06 10:26:26 |
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Basic information
Public title
CoreValve Evolut R TAV in SAV Japan Regulatory PMS
Acronym
TAV in SAV Japan Reg PMS
Scientific Title
CoreValve Evolut R TAV in SAV Japan Regulatory PMS
Scientific Title:Acronym
TAV in SAV Japan Reg PMS
Region
| Japan |
Condition
Condition
Aortic valve disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this surveillance is to confirm the safety and efficacy of the CoreValve Evolut R in patients with insufficiency of a surgical bioprosthetic aortic valve in the real world conditions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamics
Key secondary outcomes
1. Procedural success
2. Incidence of all-cause death
3. Incidence of serious stroke
4. Incidence of MACCE
5. Incidence of serious vascular complications
6. New placement of implanted heart pacemaker
7. Vessel access route
8. Conducting post-dilation of balloon catheter
9. Information related to antiplatelet therapy
10. Presence or absence of multiple valve use at the time of placement
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 with symptomatic valvular heart disease caused by the insufficiency (stenosed, closure, or combined) of a surgical bioprosthetic aortic valve, and who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment. However, chronic dialysis patients are excluded.
Key exclusion criteria
None
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kikuchi |
Organization
Medtronic Japan Co.,Ltd.
Division name
Japan Clinical and Medical Affairs, Post Market Surveillance
Zip code
1080075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
03-6776-0007
akira.kikuchi@medtronic.com
Public contact
Name of contact person
| 1st name | Moe |
| Middle name | |
| Last name | Terauchi |
Organization
Medtronic Japan Co.,Ltd.
Division name
Clinical Research and Medical Science, Evidence Solution, Post Market Surveillance
Zip code
1080075
Address
1-2-70 Konan, Minato-ku, Tokyo
TEL
03-6776-0007
Homepage URL
moe.terauchi@medtronic.com
Sponsor or person
Institute
Medtronic Japan Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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
| 2018 | Year | 06 | Month | 30 | 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
217
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2018 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037795
