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.

Berlin Heart, Inc0 sitesNovember 17, 2010

ConditionsHeart Failure Cardiomyopathies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Berlin Heart, Inc
Status: Approved For Marketing
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 17, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

Berlin Heart, Inc

Responsible Party

Sponsor

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:
•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.

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