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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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT01171950
First received: July 27, 2010
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  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: 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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171950

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

No publications provided

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT01171950     History of Changes
Other Study ID Numbers: PED-001
Study First Received: July 27, 2010
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013