About the Trial
The EARLY TAVR Trial will examine the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve (THV) versus careful observation (or clinical surveillance) in patients with severe aortic stenosis without symptoms.
The purpose of the trial is to compare results of patients that have their valves replaced early in the disease process versus patients that have the disease monitored.Download Patient Information Guide
Are you a candidate?
You may be eligible for this trial if:
- you are 65 years of age or older
- you have severe aortic stenosis
- you do not have symptoms.
Your doctor or research coordinator will discuss with you the full list of criteria for participating in the trial.
For Patients who have severe aortic stenosis and have no symptoms, a treadmill stress test helps to understand if there are symptoms during mild exercise. This test involves walking on a treadmill while your heart, blood pressure, and breathing are monitored by your doctor
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.
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