CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients
Not Applicable
Withdrawn
- Conditions
- Heart Failure
- Registration Number
- NCT01171950
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Survival 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.
- Secondary Outcome Measures
Name Time Method Evaluation of end-organ function 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