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Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583661
First Posted: December 31, 2007
Last Update Posted: March 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Berlin Heart, Inc
  Purpose
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the EXCOR® Pediatric merits approval by the Food and Drug Administration under a Humanitarian Device Exception (HDE).

Condition Intervention
Heart Failure Cardiomyopathies Device: EXCOR Pediatric

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Single Arm Study to Access the Safety and Probable Benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR Pediatric]

Further study details as provided by Berlin Heart, Inc:

Primary Outcome Measures:
  • The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device. [ Time Frame: Participants were followed while on device support, an average of 58 days ]
    The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.

  • Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device. [ Time Frame: Participants were followed while on device support, an average of 58 days ]
    Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.


Enrollment: 48
Study Start Date: May 2007
Study Completion Date: December 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EXCOR Pediatric
Implantation of the EXCOR Pediatric Ventricular Assist Device
Device: EXCOR Pediatric
Extracorporeal Ventricular Assist Device
Other Names:
  • Berlin Heart
  • EXCOR®
  • EXCOR® Pediatric Ventricular Assist Device
  • EXCOR® Pediatric VAD

Detailed Description:
Berlin Heart Inc. is sponsoring a prospective, multi-center, single arm study to access the safety and probable benefit of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device [EXCOR® Pediatric]. The study will compare the EXCOR® Pediatric with a historical control population supported with extra-corporeal membrane oxygenation (ECMO) as a bridge to cardiac transplantation in children.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • Interagency Registry for Mechanically Assisted Circulatory Support (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 Ventricular Septal Defects (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 Investigational Device Exemption (IDE) or Investigational New Drug Application (IND) trial
  • Patient is pregnant or nursing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583661


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Lucille Packard Children's Hospital / Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
The Children's Hospital Denver
Denver, Colorado, United States, 80045
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
United States, Indiana
Riley Hospital for Children
Indianapolis, Indiana, United States, 26202
United States, Massachusetts
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota - Fairview
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
United States, New York
The Mt. Sinai Hospital
New York, New York, United States, 10029
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Berlin Heart, Inc
Investigators
Principal Investigator: Charles D Fraser, MD, FACS Texas Children's Hospital / Baylor College of Medicine
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berlin Heart, Inc
ClinicalTrials.gov Identifier: NCT00583661     History of Changes
Other Study ID Numbers: EXCOR® Pediatric
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: January 25, 2012
Results First Posted: March 15, 2013
Last Update Posted: March 15, 2013
Last Verified: March 2013

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

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