Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol (CAP)
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The data collection and protocols for this study remain consistent with the main IDE study for the EXCOR® Pediatric Ventricular Assist Device. This protocol was closed at the same time as the main IDE study due to FDA approval (December 16, 2011).
A Prospective, Multi-center, Single Arm Study to Assess the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (EXCOR® Pediatric)Under a Continued Access Protocol.
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Ages Eligible for Study:
up to 16 Years (Child)
Sexes Eligible for Study:
- 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:
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
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.
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 VSD or other compromise that is technically challenging to repair at implant
Documented heparin induced thrombocytopenia (HIT)
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 IDE or IND trial