To establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosisDownload EARLY TAVR Trial HCP Brochure
Patients will undergo a treadmill stress test to determine if they are asymptomatic with severe aortic stenosis.
Negative stress test* and review Medical History
2 year composite of all-cause death, all stroke, and unplanned cardiovascular hospitalization
Positive stress test*
Commerical AVR (TAVR or SAVR)
Patient Screening Process
Investigational Device Information
SAPIEN 3 Valve
SAPIEN 3 Ultra Valve
See how it works
CAUTION: INVESTIGATIONAL DEVICES. The Edwards SAPIEN 3 / Edwards SAPIEN 3 Ultra transcatheter heart valve is an investigational device when used in asymptomatic patients. Limited by Federal (USA) law to investigational use only. These devices are not available for marketing or commercial sale in the United States for asymptomatic patients. See instructions for use for full information, including indications, contraindications, warnings, precautions, and adverse events.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3 and SAPIEN 3 Ultra are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP--US-5815 v1.0
Edwards Lifesciences ∙ One Edwards Way, Irvine CA 92614 USA
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