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

Primary Purpose

Heart Failure, Cardiomyopathies

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
EXCOR Pediatric
Sponsored by
Berlin Heart, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Ventricular Assist Device, Pediatric Ventricular Assist Device

Eligibility Criteria

1 Day - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Arkansas Children's Hospital
  • Lucille Packard Children's Hospital / Stanford University
  • The Children's Hospital Denver
  • Children's Healthcare of Atlanta
  • Riley Hospital for Children
  • Children's Hospital of Boston
  • C.S. Mott Children's Hospital
  • University of Minnesota - Fairview
  • St. Louis Children's Hospital
  • The Mt. Sinai Hospital
  • Children's Hospital of Pittsburgh
  • Texas Children's Hospital
  • Seattle Children's Hospital
  • Children's Hospital of Wisconsin
  • Stollery Children's Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EXCOR Pediatric

Arm Description

Implantation of the EXCOR Pediatric Ventricular Assist Device

Outcomes

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.
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.
Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
March 13, 2013
Sponsor
Berlin Heart, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00583661
Brief Title
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
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]
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Berlin Heart, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiomyopathies
Keywords
Ventricular Assist Device, Pediatric Ventricular Assist Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EXCOR Pediatric
Arm Type
Experimental
Arm Description
Implantation of the EXCOR Pediatric Ventricular Assist Device
Intervention Type
Device
Intervention Name(s)
EXCOR Pediatric
Other Intervention Name(s)
Berlin Heart, EXCOR®, EXCOR® Pediatric Ventricular Assist Device, EXCOR® Pediatric VAD
Intervention Description
Extracorporeal Ventricular Assist Device
Primary Outcome Measure Information:
Title
The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.
Description
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.
Time Frame
Participants were followed while on device support, an average of 58 days
Title
Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles D Fraser, MD, FACS
Organizational Affiliation
Texas Children's Hospital / Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Lucille Packard Children's Hospital / Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
The Children's Hospital Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
26202
Country
United States
Facility Name
Children's Hospital of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Minnesota - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Mt. Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25613996
Citation
Jordan LC, Ichord RN, Reinhartz O, Humpl T, Pruthi S, Tjossem C, Rosenthal DN. Neurological complications and outcomes in the Berlin Heart EXCOR(R) pediatric investigational device exemption trial. J Am Heart Assoc. 2015 Jan 22;4(1):e001429. doi: 10.1161/JAHA.114.001429.
Results Reference
derived
PubMed Identifier
22873533
Citation
Fraser CD Jr, Jaquiss RD, Rosenthal DN, Humpl T, Canter CE, Blackstone EH, Naftel DC, Ichord RN, Bomgaars L, Tweddell JS, Massicotte MP, Turrentine MW, Cohen GA, Devaney EJ, Pearce FB, Carberry KE, Kroslowitz R, Almond CS; Berlin Heart Study Investigators. Prospective trial of a pediatric ventricular assist device. N Engl J Med. 2012 Aug 9;367(6):532-41. doi: 10.1056/NEJMoa1014164.
Results Reference
derived
PubMed Identifier
21884857
Citation
Almond CS, Buchholz H, Massicotte P, Ichord R, Rosenthal DN, Uzark K, Jaquiss RD, Kroslowitz R, Kepler MB, Lobbestael A, Bellinger D, Blume ED, Fraser CD Jr, Bartlett RH, Thiagarajan R, Jenkins K. Berlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: study design and rationale. Am Heart J. 2011 Sep;162(3):425-35.e6. doi: 10.1016/j.ahj.2011.05.026. Epub 2011 Jul 30.
Results Reference
derived
Links:
URL
http://www.berlinheart.com
Description
Berlin Heart Inc. Website

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

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