UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033603 |
|---|---|
| Receipt number | R000038175 |
| Scientific Title | Japanese registry for Percutaneous Ventricular Assist Device |
| Date of disclosure of the study information | 2018/08/02 |
| Last modified on | 2018/08/02 09:03:02 |
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Basic information
Public title
Japanese registry for Percutaneous Ventricular Assist Device
Acronym
J-PVAD
Scientific Title
Japanese registry for Percutaneous Ventricular Assist Device
Scientific Title:Acronym
J-PVAD
Region
| Japan |
Condition
Condition
acute heart failure
Classification by specialty
| Cardiology | Cardiovascular surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is understanding the situation of Japanese catheter VAD usage by the registry.
Basic objectives2
Others
Basic objectives -Others
Survey of Japanese actual IMPELLA usage
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
30days mortality after device implantation
Key secondary outcomes
adverse event related to device useage
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
All patient who were implanted catheter VAD for acute heart failure in Japan will be enrolled.
Key exclusion criteria
No patient who were implanted catheter VAD for acute heart failure in Japan will not be excluded.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Graduate School of Medicine/ Faculty of Medicine, Osaka university
Division name
Cardiovascular Surgery
Zip code
Address
2-2 yamadaoka, Suita city, Osaka prefecture
TEL
06-6879-5111
sawasec@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ikuko Akamatsu |
Organization
Japan VAD Council
Division name
IMPELLA Committee
Zip code
Address
2-2 yamadaoka, Suita city, Osaka prefecture
TEL
06-6879-5111
Homepage URL
info@j-pvad.jp
Sponsor or person
Institute
Japan VAD Council, IMPELLA Committee
Institute
Department
Personal name
Funding Source
Organization
Japan VAD Council
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
Address
Tel
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 | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 08 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Corrected data will be used for Post Market Survey by the company.
Management information
Registered date
| 2018 | Year | 08 | Month | 02 | Day |
Last modified on
| 2018 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038175
