Trial ID or NCT#
The purpose of this post approval study is to determine the safety, effectiveness and learning curve of the SAPIEN™ THV with the Retroflex delivery system for Inoperable Patients and with the SAPIEN™ THV with Retroflex and Ascendra delivery systems for high risk operable patients with Severe Symptomatic Native Aortic Stenosis via all access sites.
Assessment of Safety, Effectiveness, Adherence to Indication and Learning Curve of the SAPIEN™ THV With Retroflex for Inoperable Patients and With RetroFlex or Ascendra for High Risk Operable Patients Post Approval Period (US)
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Spectrum Child Health