CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
|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|
- 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.
- 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
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171950
|Study Director:||Mark Macedo, BSN||Thoratec Corporation|