Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device

The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).

Berlin Heart Inc. is sponsoring a prospective, multi-center, single arm study to access the safety and probable benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device \[EXCOR® Pediatric\]. The study will compare the EXCOR® Pediatric with a historical control population supported with extra-corporeal membrane oxygenation (ECMO) as a bridge to cardiac transplantation in children.

Eligibility Criteria:
Inclusion Criteria:

- Severe New York Heart Association (NYHA) Functional Class IV (or Ross Functional Class IV for patients \<= 6 years) heart failure refractory to optimal medical therapy, and has met at least one of the following criteria:

* Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile status 1 or 1a, i.e. critical cardiogenic shock (low BP unresponsive to support), compromised end organ perfusion, \< 24 hour survival without mechanical support; may be due to Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) (1A) OR
* INTERMACS profile status 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: Decline in renal functions, Decline in nutritional status, Decline in mobility/ambulation

OR

* Support with extra-corporeal membrane oxygenation (ECMO) or other mechanical circulatory support device OR
* Unable to separate from cardiopulmonary bypass

  * Listed (UNOS status 1A or equivalent) for cardiac transplantation
  * Two-ventricle circulation, including cardiomypathy, repaired structural heart disease or acquired heart disease
  * Age 0 to 16 years
  * Weight \>= 3 kg and \<= 60 kg
  * Legal guardian (and patient if age-appropriate) understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent and assent prior to the procedure

Exclusion Criteria:

* Support on ECMO for \>= 10 days
* Cardiopulmonary resuscitation (CPR) duration \>= 30 minutes within 48 hours of implantation
* Body weight \< 3.0 kg or Body Surface Area \> 1.5 m2
* Presence of mechanical aortic valve
* Unfavorable or technically-challenging cardiac anatomy including single ventricle lesions, complex heterotaxy, and restrictive cardiomyopathy
* Evidence of intrinsic hepatic disease
* Evidence of intrinsic renal disease
* Evidence of intrinsic pulmonary disease
* Hemodialysis or peritoneal dialysis (not including dialysis or continuous veno-venous hemofiltration (CVVH) for fluid removal)
* Moderate or severe aortic and/or pulmonic valve insufficiency
* Apical Ventricular Septal Defects (VSD) or other compromise that is technically challenging to repair at implant
* Documented heparin induced thrombocytopenia (HIT)
* Documented coagulopathy
* Hematologic disorder
* Active Infection within 48 hours of implant (positive blood culture or White Blood Cell Count \>15,000 and fever \> 38 degrees C)
* Documented Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
* Evidence of recent life-limiting malignant disease
* Stroke within 30 days prior to enrollment
* Psychiatric or behavioral disease
* Currently participating in another Investigational Device Exemption (IDE) or Investigational New Drug Application (IND) trial
* Patient is pregnant or nursing