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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040456
Receipt No. R000046173
Scientific Title A comparison of novel developed centrifugal-flow and conventional pulsatile-flow extracorporeal left ventricular assist devices in patients with cardiogenic shock : Sub-analysis of NCVC-BTD_01 trial
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/20

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Basic information
Public title A comparison of novel developed centrifugal-flow and conventional pulsatile-flow extracorporeal left ventricular assist devices in patients with cardiogenic shock : Sub-analysis of NCVC-BTD_01 trial
Acronym A comparison of centrifugal- and pulsatile-flow extracorporeal LVAD
Scientific Title A comparison of novel developed centrifugal-flow and conventional pulsatile-flow extracorporeal left ventricular assist devices in patients with cardiogenic shock : Sub-analysis of NCVC-BTD_01 trial
Scientific Title:Acronym A comparison of centrifugal- and pulsatile-flow extracorporeal LVAD
Region
Japan

Condition
Condition Patients who were implanted with extracorporeal left ventricular assist device at the National Cerebral and Cardiovascular Center in Japan
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our aim of this study is to compare the clinical prognosis between a novel centrifugal-flow extracorporeal left ventricular assist device (E-LVAD) (BR16010) and a conventional pulsatile-flow E-LVAD in patients with cardiogenic shock.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We assess the death and major cardiac events 60 days after ELVAD implantation.
Key secondary outcomes We also assess the changes in organ dysfunction including liver and renal function and cardiac function early phase after E-LVAD implantation.

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were implanted with extracorporeal left ventricular assist device at the National Cerebral and Cardiovascular Center in Japan
Key exclusion criteria Subjects without informed consent
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Norihide
Middle name
Last name Fukushima
Organization National Cerebral and Cardiovascular Center
Division name Department of transplant medicine
Zip code 564-8565
Address 6-1, Kishibe-shinmachi, Suita, Osaka, Japan
TEL 0661701069
Email nori@ncvc.go.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Watanabe
Organization National Cerebral and Cardiovascular Center
Division name Department of transplant medicine
Zip code 564-8565
Address 6-1, Kishibe-shinmachi, Suita, Osaka, Japan
TEL 0661701069
Homepage URL
Email watanabe.takuya@ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Ministry of education, culture, sports, science and technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cerebral and Cardiovascular Center
Address National Cerebral and Cardiovascular Center
Tel 0661701070
Email rec-office-ac@ncvc.go.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
2020 Year 05 Month 20 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 Open public recruiting
Date of protocol fixation
2020 Year 03 Month 02 Day
Date of IRB
2020 Year 04 Month 28 Day
Anticipated trial start date
2020 Year 03 Month 02 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under observation

Management information
Registered date
2020 Year 05 Month 20 Day
Last modified on
2020 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046173

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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