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Heart FailureNCT00583661

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

A study testing EXCOR Pediatric in people with Heart Failure and Cardiomyopathies, run by Berlin Heart, Inc at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 day to 16 years
Conditions the study is for
Heart Failure, Cardiomyopathies
What is being tested?
EXCOR Pediatric
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
17 sitesin 2 countries
Study dates
May 2007to Dec 2011
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States15 sites

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109

  • Children's Healthcare of Atlanta

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Children's Hospital of Boston

    Boston, Massachusetts, 02115

  • The Children's Hospital Denver

    Denver, Colorado, 80045

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Hospital for Children

    Indianapolis, Indiana, 26202

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota - Fairview

    Minneapolis, Minnesota, 55455

  • The Mt. Sinai Hospital

    New York, New York, 10029

  • Lucille Packard Children's Hospital / Stanford University

    Palo Alto, California, 94304

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

Other trials in United States

Canada2 sites

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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]

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).

Read the 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.

Being tested
EXCOR Pediatric
Keywords
Ventricular Assist Device, Pediatric Ventricular Assist Device
Medical subject headings
Heart Failure, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXCOR PediatricDevice

    Also called Berlin Heart, EXCOR®, EXCOR® Pediatric Ventricular Assist Device, EXCOR® Pediatric VAD

    Extracorporeal Ventricular Assist Device

Study groups in NCT00583661
Study groupRoleWhat they receive
EXCOR PediatricExperimentalImplantation of the EXCOR Pediatric Ventricular Assist Device
Receives: Device: EXCOR Pediatric

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionSep 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00583661
Sponsor's protocol ID
EXCOR® Pediatric
Status last verified
Mar 2013
First submitted
20 Dec 2007
Last updated
15 Mar 2013
Data monitoring committee
Yes
Expanded access
Available

Publications

  • 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.

    PubMed 25613996

  • 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.

    PubMed 22873533

  • 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.

    PubMed 21884857

Questions about this trial

What is this clinical trial studying?

A study testing EXCOR Pediatric in people with Heart Failure and Cardiomyopathies, run by Berlin Heart, Inc at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00583661, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2013.

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