The SAPIEN 3 THV System was recently approved for use in patients with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention. The objective of this study is to monitor device performance and outcomes in the post-approval setting.
What is the full name of this clinical trial?
COngenital Multicenter trial of Pulmonic vAlve dysfunction Studying the SAPIEN 3? InterventIONal THV Post-Approval Study