assess safety and probable benefit of the excor® pediatric ventricular assist device

Conditions: Heart Failure; Cardiomyopathies

Summary: 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 \ 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

Keywords: ventricular assist device pediatric ventricular assist device