NCT00583661

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable heart-failure

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2013

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

3.3 years

First QC Date

December 20, 2007

Results QC Date

January 25, 2012

Last Update Submit

March 13, 2013

Conditions

Heart FailureCardiomyopathies

Keywords

Ventricular Assist DevicePediatric Ventricular Assist Device

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

    Participants were followed while on device support, an average of 58 days

Study Arms (1)

EXCOR Pediatric

EXPERIMENTAL

Implantation of the EXCOR Pediatric Ventricular Assist Device

Device: EXCOR Pediatric

Interventions

EXCOR PediatricDEVICE

Extracorporeal Ventricular Assist Device

Also known as: Berlin Heart, EXCOR®, EXCOR® Pediatric Ventricular Assist Device, EXCOR® Pediatric VAD
EXCOR Pediatric

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- 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
  • 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

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Lucille Packard Children's Hospital / Stanford University

Palo Alto, California, 94304, United States

Location

The Children's Hospital Denver

Denver, Colorado, 80045, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 26202, United States

Location

Children's Hospital of Boston

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota - Fairview

Minneapolis, Minnesota, 55455, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

The Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

  • 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.

    PMID: 25613996DERIVED

  • 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.

    PMID: 22873533DERIVED

  • 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.

    PMID: 21884857DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Robert Kroslowitz, CEO
Organization
Berlin Heart Inc.
kroslowitz@berlinheart.com
1-281-863-9700

Study Officials

  • Charles D Fraser, MD, FACS

    Texas Children's Hospital / Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2010

Study Completion

December 1, 2011

Last Updated

March 15, 2013

Results First Posted

March 15, 2013

Record last verified: 2013-03

Locations

CA(2)US(15)