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

NCT01242891 | Unknown

• 1 other identifier: EXCOR® Continued Access
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Cardiomyopathies

Keywords

Ventricular Assist Device; Pediatric Ventricular Assist Device

Interventions

EXCOR® Pediatric Ventricular Assist Device DEVICE

Extracorporeal Ventricular Assist Device

Also known as: Berlin Heart, EXCOR®, EXCOR® Pediatric, EXCOR® Pediatric VAD

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Age Groups: Child (0-17)

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:
• 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.

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 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)

Sponsors & Collaborators

• Berlin Heart, Inc: lead

Related Links

• Berlin Heart Inc

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• All Previous IDE Sites

  See IDE Clinical Trials Listing for IDE Study

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2010
• First Posted: November 17, 2010
• Last Updated: March 6, 2012

Record last verified: 2012-03