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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033216
Receipt No. 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 2020/07/01

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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 Koichi
Middle name
Last name Uchiyama
Organization Medtronic Japan Co.,Ltd.
Division name Clinical Affairs, Post Market Surveillance Division
Zip code 1080075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL 03-6776-0007
Email hiroshi.ono@medtronic.com

Public contact
Name of contact person
1st name Maiko
Middle name
Last name Kawano
Organization Medtronic Japan Co.,Ltd.
Division name Clinical Affairs, Post Market Surveillance Division
Zip code 1080075
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL 03-6776-0007
Homepage URL
Email maiko.kawano@medtronic.com

Sponsor
Institute Medtronic Japan Co.,Ltd.
Institute
Department

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
Email 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
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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