Status:
WITHDRAWN
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
5-16 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Age 5 years to 16 years, inclusive
- Inability to wean from cardiopulmonary bypass (CPB)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01171950
Start Date
June 1 2009
End Date
December 1 2012
Last Update
June 24 2022
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