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

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 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.

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