Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Ventricular Assist Device
Dose form / Japanese Medical Device Nomenclature:OTHER
Extracorporeal, pneumatically driven ventricular assist device
Route of a
Sponsors
Ono, Minoru, MD, PhD, Cardiac Surgery, The University of Tokyo Hospital
The university of Tokyo Hospital, Murakami, Arata
Osaka University Hospital, Sawa, Yoshiki
National Cerebral and Cardiovascular Center, Nakatani, Taketsugu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Listed for cardiac transplantation(Japan organ transplant network) 2 Age 0 to 14 years; corrected gestational (CGA) at least 37 weeks 3 Weight ? 3 kg or < 50 kg and Body surface area <1.5 m2 4. Severe NYHA Functional Class IV (or Ross Functional Class IV for subjects ?6 years) heart failure refractory to optimal medical therapy, and has met at least one of the following criteria: a. J-MACS profile status 1 or 1A, i.e. critical cardiogenic shock (low BP unresponsive to support), compromised end organ perfusion, < 24 hour survival expected without mechanical support; may be due to VT/VF (1A) b.J-MACS profile status 2 or 2A (i.e. progressive decline): not in imminent danger, but worsening despite optimal inotropic therapy; may be due to VT/VF (2A) AND at least one of the following criteria i. Decline in renal function as defined by a 50% reduction in estimated GFR despite optimization of subject volume status ii. Decline in nutritional status as defined by a sustained (?7 days) inability to tolerate an enteral nutritional intake sufficient to provide at least 75% of the prescribed caloric needs for the subject, or signs of nutritional compromise (cachexia, nutritional weight loss) despite appropriate intervention iii. Decline in mobility/ambulation as defined by sustained bed confinement (?7 days without prospect for improvement) attributable to heart failure symptoms or its treatment (e.g. intubation for pulmonary edema) c. Support with extra-corporeal membrane oxygenation (ECMO) or other mechanical circulatory support device 5. Two-ventricle circulation, including cardiomyopathy, repaired structural heart disease (e.g. ALCAPA, aortic stenosis) or acquired heart disease (e.g. myocarditis, Kawasaki disease) 6. Legal guardian (and subject if age-appropriate) understands the nature of the procedure, are willing to comply with associated follow-up evaluations, and provide written informed consent and assent prior to the procedure
Exclusion criteria
Exclusion criteria: 1. Support on ECMO for ?10 days 2. Cardiopulmonary resuscitation (CPR) duration ?30 minutes within 48 hours prior to device implantation 3. Presence of mechanical aortic valve 4. Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy 5. Evidence of intrinsic hepatic disease, except in association with acute heart failure as determined by the principal investigator 6. Evidence of intrinsic renal disease, except in association with acute heart failure as determined by the principal investigator 7. Hemodialysis or peritoneal dialysis (not including dialysis or Continuous Veno-Venous Hemofiltration (CVVH) for volume removal) 8. Evidence of intrinsic pulmonary disease (e.g. chronic lung disease, RDS) as defined by need for chronic mechanical ventilation, except in association with acute heart failure as determined by the principal investigator 9. Moderate or severe aortic and/or pulmonic valve insufficiency considered technically challenging to repair at the time of the device implantation as determined by the principal investigator 10. Apical VSD or other hemodynamically-significant lesion considered technically challenging to repair at the time of device implantation as determined by the principal investigator 11. Documented heparin induced thrombocytopenia (HIT) or idiopathic thrombocytopenia purpura (ITP) or other contraindication to anticoagulant/antiplatelet therapy 12. Documented coagulopathy (e.g. Factor VIII deficiency, disseminated intravascular coagulation) or thrombophilic disorder (e.g. Factor V Leiden mutation) 13. Hematologic disorder causing fragility of blood cells or hemolysis (e.g. sickle cell disease) 14. Active infection within 48 hours of implant demonstrated by: a. Positive blood culture OR b. Temperature >38 degrees C and WBC >15, 000/ ml 15. Documented human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) 16. Evidence of recent or life-limiting malignant disease 17. Stroke within past 30 days prior to enrollment, or congenital CNS malformation syndrome associated with increased risk of bleeding (e.g. arteriovenous malformation, moya moya) 18. Psychiatric or behavioral disease (e.g. antisocial disorder) with a high likelihood for noncompliance 19. Currently participating in another investigational device or drug trial and has not completed the required follow-up period for that study 20. Subjects who are not appropriate to participate to the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (efficacy) Subjects status will be evaluated during 3months after the initiation of mechanical support. (safety) adverse event, device malfunction | — |
Secondary
| Measure | Time frame |
|---|---|
| (efficacy) 1.The interval of time from initiation of mechanical support to the following event 2. Ability to de-intensify concomitant hemodynamic support by analyzing the subjects status | — |
Countries
Japan
Contacts
Public ContactMakoto Akabori
The University of Tokyo Hospital
Outcome results
None listed