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

This treatment has been approved for sale to the public.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014