2 results
Approved WMOCompleted
Study Purpose and ObjectivesStudy PurposeTo confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by NYHA functional classification, hemodynamic performance,…
Approved WMOCompleted
Primary objectives: - To test the hypothesis that a relationship between mitochondrial oxygenation and serum lactate existsSecondary objectives:- To provide data for estimating the number of patients needed for a clinical trial to prove the above…