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)) etc.] and severe respiratory failure refractory to optimal medical management, standard surgical procedure including lung transplantation, volume reduction surgery etc., oxygen therapy, physical therapy and
Conditions
Interventions
The ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) is implanted within 3 days after study entry. BR13030 is withdrawn during 14 days after implantation of a trial device. BR1
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.Underlying disorders causing serious heart failure or refractory cardiogenic shock 1.low cardiac output syndrome due to cardiac disorders (idiopathic, secondary or ischemic cardiomyopathy, or myocarditis) 2.post-acute myocardial infarction circulatory failures (including mechanic complication or refractory arrhythmia) 3. difficulty in withdrawal of cardiopulmonary bypass 4. postoperative low cardiac output syndrome (including refractory arrhythmia) 5. other cardiogenic circulatory failures (including refractory arrhythmia) b. Underlying disorders causing severe respiratory failure 1.severe infectious (viral or bacterial) and aspiration pneumonia 2.acute respiratory distress syndrome (ARDS) 3.bridge to lung transplantation, primary lung graft failure such as reperfusion injury 4.difficulty in withdrawal of cardiopulmonary support due to respiratory failure 5.transient respiratory failure in patients with chronic lung disease 6.heavy asthma attack 7.other acute respiratory failures 2) Body weight not lower than 10kg at the time of informed consent 3) Written informed consent of the patient or his/her 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) Contraindicated for anticoagulation 5) Difficulty of 14-day observation is anticipated 6) Participating in another clinical trial at time of study entry 7) 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: Cardiac and/or respiratory function recovery during 14 days after implantation of a trial device | — |
Secondary
| Measure | Time frame |
|---|---|
| Common secondary outcomes 1)Total support period of a trial device 2)Removal of mechanical ventilation during device support and interval between implantation and withdrawal of a trial device 3)Device-unrelated death All death during device support (max. 14 days) 4)Suspiciously dDevice-related death between implantation and 7days after withdrawal of a trial device 5)Adverse events and device failure Outcomes of VA ECMO 1)Changes in brain natriuretic peptide (BNP) levels (7 days after implantation and the day of withdrawal of a trial device) 2)Changes in left ventricular ejection fraction (LVEF)(7 days after implantation and the day of withdrawal of a trial device) 3)Changes in left ventricular diastolic dimension (LVDd)(7 days after implantation and the day of withdrawal of a trial device) Outcomes of VV ECMO 1)Arterial oxygen and carbon dioxide partial pressure (PaO2 and PaCO2)(7 days after implantation and the day of withdrawal of a trial device) | — |
Countries
Japan
Contacts
Public ContactTakuya Watanabe
National Cerebral and Cardiovascular Center Department of Transplant Medicine
Outcome results
None listed