UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040456 |
|---|---|
| Receipt number | 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 | 2021/11/30 13:56:41 |
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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
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
watanabe.takuya@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
Completed
Management information
Registered date
| 2020 | Year | 05 | Month | 20 | Day |
Last modified on
| 2021 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046173
