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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033603
Receipt No. R000038175
Official scientific title of the study Japanese registry for Percutaneous Ventricular Assist Device
Date of disclosure of the study information 2018/08/02
Last modified on 2018/08/02

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Basic information
Official scientific title of the study Japanese registry for Percutaneous Ventricular Assist Device
Title of the study (Brief title) 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 Yoshiki Sawa
Organization Graduate School of Medicine/ Faculty of Medicine, Osaka university
Division name Cardiovascular Surgery
Address 2-2 yamadaoka, Suita city, Osaka prefecture
TEL 06-6879-5111
Email sawasec@surg1.med.osaka-u.ac.jp

Public contact
Name of contact person Ikuko Akamatsu
Organization Japan VAD Council
Division name IMPELLA Committee
Address 2-2 yamadaoka, Suita city, Osaka prefecture
TEL 06-6879-5111
Homepage URL
Email info@j-pvad.jp

Sponsor
Institute Japan VAD Council, IMPELLA Committee
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 24 Day
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

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038175

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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