Status:
COMPLETED
SynCardia CardioWest TAH-t Postmarket Surveillance Study
Lead Sponsor:
SynCardia Systems. LLC
Conditions:
Biventricular Failure
Eligibility:
All Genders
Brief Summary
The purpose of this study is to demonstrate that the results achieved in the original pivotal clinical investigation of 81 subjects from five clinical sites are generalizable to new clinical sites tha...
Eligibility Criteria
Inclusion
- The TAH-t is indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
Exclusion
- Patients who are not cardiac transplant eligible.
- Patients who do not have sufficient space in the chest area vacated by the natural ventricles. Generally this includes patients who have body surface areas \<1.7m², or who have a distance between the sternum and the 10th anterior vertebral body measured by computed tomography imaging (CT scan) \< 10 cm.
- Patients who cannot be adequately anticoagulated on the TAH-t.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00614510
Start Date
August 1 2006
End Date
March 1 2015
Last Update
July 30 2015
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