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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171950
First Posted: July 29, 2010
Last Update Posted: April 11, 2016
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):
St. Jude Medical ( Thoratec Corporation )
  Purpose
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 Intervention
Heart Failure Device: CentriMag Ventricular Assist System

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical ( Thoratec Corporation ):

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 0
Study Start Date: June 2009
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  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): NCT01171950


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

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01171950     History of Changes
Other Study ID Numbers: PED-001
First Submitted: July 27, 2010
First Posted: July 29, 2010
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