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Withdrawn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
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Thoratec Corporation
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
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
NCT ID
NCT01171950
First Posted
July 27, 2010
Last Updated
June 23, 2022
Sponsor
Abbott Medical Devices
Collaborators
Thoratec Corporation
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Withdrawn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
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