UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029065 |
|---|---|
| Receipt number | 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 | 2021/04/05 16:01:33 |
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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
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
seguchi.osamu.hp@mail.ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
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
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
https://doi.org/10.1007/s10557-018-6796-8
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32461539/
Number of participants that the trial has enrolled
9
Results
Nine patients were enrolled. Six had INTERMACS profile 1, and 3 were profile 2. Eight patients received LVAD. One patient with fulminant myocarditis received biventricular support using the novel VAD system. 3 patients were weaned from VAD and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died.
Results date posted
| 2021 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 05 | Month | 28 | Day |
Baseline Characteristics
Nine patients, comprising 3 with dilated cardiomyopathy, 3 with fulminant myocarditis, and 3 with ischemic heart disease, and 6 males, whose mean age was 47.7+/-8.1 years, were enrolled into the study. Six patients had Interagency Registry for Mechanically Assisted Circulatory Support profile 1, and 3 were profile 2.
Participant flow
All 9 participants were implanted with a trial device and followed-up 2 weeks after removal of a trial device.
Adverse events
One patient had non-disabling ischemic stroke episodes, and no patients died.
Outcome measures
After 19.0+/-13.5 days, 3 patients were weaned from circulatory support, because their native cardiac function recovered, and 6 patients required conversion to a durable device as a bridge-to-transplantation. One patient had non-disabling ischemic stroke episodes, and no patients died.
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
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033243
