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