CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
|ClinicalTrials.gov Identifier: NCT01171950|
Recruitment Status : Withdrawn
First Posted : July 29, 2010
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: CentriMag Ventricular Assist System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CentriMag Ventricular Assist System (VAS): Treatment of Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients|
|Study Start Date :||June 2009|
|Estimated Primary Completion Date :||December 2012|
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.
- Survival [ Time Frame: 30 days after device removal, or, induction of anesthesia for implant of a long-term device or heart transplant ]
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 ]Improvements in measures of end-organ function
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171950
|Study Director:||Mark Macedo, BSN||Thoratec Corporation|