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 stenosis
Patients will undergo a treadmill stress test to determine if they are asymptomatic with severe aortic stenosis.
Negative stress test* OR confirmation via 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
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We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center. For details about this trial, visit NCT03042104 at ClinicalTrials.gov
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.
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