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

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Sponsor:
Information provided by (Responsible Party):
Berlin Heart, Inc
ClinicalTrials.gov Identifier:
NCT01242891
First received: November 16, 2010
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Heart Failure
Cardiomyopathies
Device: EXCOR® Pediatric Ventricular Assist Device

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Berlin Heart, Inc:

Intervention Details:
    Device: EXCOR® Pediatric Ventricular Assist Device
    Extracorporeal Ventricular Assist Device
    Other Names:
    • Berlin Heart
    • EXCOR®
    • EXCOR® Pediatric
    • EXCOR® Pediatric VAD
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).

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242891

Sponsors and Collaborators
Berlin Heart, Inc
Investigators
Principal Investigator: All Previous IDE Sites See IDE Clinical Trials Listing for IDE Study
  More Information

Additional Information:
No publications provided

Responsible Party: Berlin Heart, Inc
ClinicalTrials.gov Identifier: NCT01242891     History of Changes
Other Study ID Numbers: EXCOR® Continued Access
Study First Received: November 16, 2010
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Berlin Heart, Inc:
Ventricular Assist Device
Pediatric Ventricular Assist Device

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014