Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol

• Conditions: Heart Failure; Cardiomyopathies

• Registration Number: NCT01242891
• Lead Sponsor: Berlin Heart, Inc

Brief Summary

The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-02
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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:

• 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 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 IDE or IND trial
• Patient is pregnant or nursing

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified