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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029065
Receipt No. R000033243
Scientific Title Single-arm study for assessment of safety and effectiveness of the extracorporeal continuous-flow ventricular assist device (BR16010) use as a bridge-to-decision therapy for severe heart failure or refractory cardiogenic shock
Date of disclosure of the study information 2017/09/20
Last modified on 2018/09/10

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Basic information
Public title Single-arm study for assessment of safety and effectiveness of the extracorporeal continuous-flow ventricular assist device (BR16010) use as a bridge-to-decision therapy for severe heart failure or refractory cardiogenic shock
Acronym NCVC-BTD_01
Scientific Title Single-arm study for assessment of safety and effectiveness of the extracorporeal continuous-flow ventricular assist device (BR16010) use as a bridge-to-decision therapy for severe heart failure or refractory cardiogenic shock
Scientific Title:Acronym NCVC-BTD_01
Region
Japan

Condition
Condition Subjects with severe heart failure or cardiogenic shock refractory to optimal medical management, standard surgical procedures, or mechanical circulatory supports [e.g. intra-aortic balloon pumping (IABP), ventriculo-arterial bypass (VA bypass) and percutaneous cardiopulmonary support (PCPS))]
Classification by specialty
Cardiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to assess the safety and effectiveness of the extracorporeal continuous-flow ventricular assist device (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Safety:
Device-related serious adverse events and complications during device support

Effectiveness:
For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other VAD during 30 days after implantation
For right ventricular assistance, withdrawal of trial device due to right ventricular function recovery within 30 days after implantation
Key secondary outcomes 1) Changes in brain natriuretic peptide (BNP) levels (7 days after implantation of a trial device and the day of withdrawal of a trial device)
2) Period of mechanical ventricular support
3) Changes in left ventricular ejection fraction (LVEF) (7 days after implantation of a trial device and the day of withdrawal of a trial device)
4) Changes in left ventricular diastolic dimension (LVDd)(7 days after implantation of a trial device and the day of withdrawal of a trial device)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The extracorporeal continuous-flow ventricular assist device (BR16010) is implanted within 3 days after study entry. BR16010 is withdrawn during 30 days after implantation. The patients are observed for safety during 7 days after withdrawal of BR16010.
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 1) Serious heart failure or refractory cardiogenic shock due to the following diseases, which does not respond to optimal medication and mechanical support
a) low cardiac output syndrome due to cardiac disorders (idiopathic, secondary or ischemic cardiomyopathy, or myocarditis)
b) post-acute myocardial infarction circulatory failures (including mechanical complication or refractory arrhythmia)
c) difficulty in withdrawal of mechanical circulatory support
d) postoperative low cardiac output syndrome (including refractory arrhythmia)
e) other cardiogenic circulatory failures (including refractory arrhythmia)
2) Fully recovery is not expected with optimal medication, standard surgical procedures, and mechanical circulatory support
3) Body weight not lower than 10kg at the time of informed consent
4) NYHA IV (Ross IV for children less than 7 y.o.) and at least one of the following conditions
(a)INTERMACS/ JMACS Profile status 1 or 1A(b)INTERMACS/ JMACS Profile status 2 or 2A
(c)Currently supported with extracorporeal membrane oxygenation (ECMO) or percutaneous cardiopulmonary support device (PCPS)
5) Written informed consent of the patient or his/hers relatives
Key exclusion criteria 1)Unfavorable or technically-challenging cardiac anatomy
2)Evidence of irreversible hepatic disease (except when the primary investigator deems it as a sign of acute heart failure)
3)Evidence of irreversible renal disease (except when the primary investigator deems it as a sign of acute heart failure)
4)Evidence of irreversible intrinsic respiratory disease (e.g. chronic pulmonary disease, acute respiratory distress syndrome) which needs mechanical respiratory support (except when the primary investigator deems it as a sign of acute heart failure)
5)Contraindicated for anticoagulation
6)Difficulty of 30-day observation is anticipated
7)Pregnant, or suspected pregnant at time of study entry
8)Participating in another clinical trial at time of study entry
9)Deemed unsuitable by the primary investigator for other reasons
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihide Fukushima
Organization National Cerebral and Cardiovascular Center
Division name Department f Transplant Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Email nori@ncvc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Osamu Seguchi
Organization National Cerebral and Cardiovascular Center
Division name Department of Transplant Medicine
Zip code
Address 5-7-1 Fujishiro-dai, Suita, Osaka
TEL 06-6833-5012
Homepage URL
Email seguchi.osamu.hp@mail.ncvc.go.jp

Sponsor
Institute National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization Nipro Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立循環器病研究センター National Cerebral and Cardiovascular Center

Other administrative information
Date of disclosure of the study information
2017 Year 09 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 Completed
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 Year 05 Month 07 Day
Date of closure to data entry
2018 Year 06 Month 08 Day
Date trial data considered complete
2018 Year 07 Month 03 Day
Date analysis concluded
2018 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 08 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033243

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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