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))]
Conditions
Interventions
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 BR16010 is withdrawn during 30 days after implantation.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 f
Sponsors
National Cerebral and Cardiovascular Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactOsamu Seguchi
National Cerebral and Cardiovascular Center Department of Transplant Medicine
Outcome results
None listed