SynCardia CardioWest TAH-t Postmarket Surveillance Study

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2006
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 that complete the staff training defined in the SynCardia Systems, Inc. Training Manual and who enroll subjects who meet the intended use defined in the product Instructions for Use.
Epistemonikos ID: a8ba34139daacaf95cf0516cb8d52388d6f216cf
First added on: May 04, 2024