search
Back to results

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

Primary Purpose

Heart Failure

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CentriMag Ventricular Assist System
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Thoratec Corporation

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    All Patients

    Arm Description

    All patients meeting the patient selection criteria will be treated with the CentriMag device.

    Outcomes

    Primary Outcome Measures

    Survival
    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
    Improvements in measures of end-organ function

    Full Information

    First Posted
    July 27, 2010
    Last Updated
    June 23, 2022
    Sponsor
    Abbott Medical Devices
    Collaborators
    Thoratec Corporation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01171950
    Brief Title
    CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
    Official Title
    CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    December 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abbott Medical Devices
    Collaborators
    Thoratec Corporation

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Thoratec Corporation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    All Patients
    Arm Type
    Other
    Arm Description
    All patients meeting the patient selection criteria will be treated with the CentriMag device.
    Intervention Type
    Device
    Intervention Name(s)
    CentriMag Ventricular Assist System
    Intervention Description
    All patients will be treated with the CentriMag device for up to 30 days.
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    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.
    Time Frame
    30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant
    Secondary Outcome Measure Information:
    Title
    Evaluation of end-organ function
    Description
    Improvements in measures 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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 5 years to 16 years, inclusive Inability to wean from cardiopulmonary bypass (CPB) Exclusion Criteria: Body weight < 20 kg Severe aortic insufficiency Unrestricted intra-cardiac communications (i.e. large VSD) Pulmonary vascular resistance index (PVRI) > 10 IU Presence of DIC On hemodialysis (excluding hemofiltration) Contraindications to systemic anticoagulation Active systemic infection unresponsive to antibiotics Unresolved malignancy On other investigational VAS
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pooja Chatterjee
    Organizational Affiliation
    Thoratec Corporation/Abbott
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs