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CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients

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ClinicalTrials.gov Identifier: NCT01171950
Recruitment Status : Withdrawn
First Posted : July 29, 2010
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )

Brief Summary:
The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.

Condition or disease Intervention/treatment Phase
Heart Failure Device: CentriMag Ventricular Assist System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
Study Start Date : June 2009
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
All Patients
All patients meeting the patient selection criteria will be treated with the CentriMag device.
Device: CentriMag Ventricular Assist System
All patients will be treated with the CentriMag device for up to 30 days.




Primary Outcome Measures :
  1. Survival [ Time Frame: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant ]

    In patients who recover and do not go on to transplantation or a long-term device:

    • Survival 30 days after removal of the CentriMag VAS or to discharge, whichever is longer.

    In patients who do not recover:

    • Ability to be removed from the CentriMag VAS and survive to induction of anesthesia for implantation of a long-term device or heart transplantation.



Secondary Outcome Measures :
  1. Evaluation of end-organ function [ Time Frame: 30 days after device removal, or, to induction of anesthesia for implant of a long-term device or heart transplant ]
    Improvements in measures of end-organ function



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 5 years to 16 years, inclusive
  2. Inability to wean from cardiopulmonary bypass (CPB)

Exclusion Criteria:

  1. Body weight < 20 kg
  2. Severe aortic insufficiency
  3. Unrestricted intra-cardiac communications (i.e. large VSD)
  4. Pulmonary vascular resistance index (PVRI) > 10 IU
  5. Presence of DIC
  6. On hemodialysis (excluding hemofiltration)
  7. Contraindications to systemic anticoagulation
  8. Active systemic infection unresponsive to antibiotics
  9. Unresolved malignancy
  10. On other investigational VAS

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): NCT01171950


Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: Mark Macedo, BSN Thoratec Corporation

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01171950     History of Changes
Other Study ID Numbers: PED-001
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: April 11, 2016
Last Verified: April 2016

Keywords provided by St. Jude Medical ( Thoratec Corporation ):
Thoratec Corporation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases