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

Completed · Not applicable

Conditions studied: Heart Failure, Cardiomyopathies

In brief

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).

Key facts

Study ID

NCT00583661

Run by

Berlin Heart, Inc

People needed

48

Starts

2007-05-01

Expected to finish

2011-12-01

Last updated by the study team

2013-03-15

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Lucille Packard Children's Hospital / Stanford University — Palo Alto, California, United States
• The Children's Hospital Denver — Denver, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Children's Hospital of Boston — Boston, Massachusetts, United States
• C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• University of Minnesota - Fairview — Minneapolis, Minnesota, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• The Mt. Sinai Hospital — New York, New York, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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