|Age:||65 years or older|
|Keywords:||AsYmptomatic Severe Aortic Stenosis|
If you are eligible to take part in the main study you will have a fifty-fifty chance of being assigned to one of two groups: either TAVR or Clinical Surveillance. Neither you nor your study doctor may choose which group you will be assigned.
Devices The Edwards SAPIEN 3 THV is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position. The valve has leaflets (made of biological material derived from cows) to direct the flow of blood in your heart.
The Edwards SAPIEN 3 THV and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV.
Study Procedures – TAVR Group
If you are assigned to the TAVR Group, your aortic valve will be replaced with the SAPIEN 3 valve. The procedure will be performed in a cardiac catheterization laboratory or hybrid operating room. The procedure can be performed under local or general anesthesia. The study team will discuss the valve implantation process with you in great detail.
You will return to the hospital for follow-up evaluations at 30 days, and at 1, 2, 3 and 5 years after the implant procedure.
Study Procedures – Clinical Surveillance Group If you are assigned to the Clinical Surveillance Group, you will be evaluated one year after randomization to determine whether your aortic valve needs to be replaced. This will be done again at 2, 3 and 5 years.
Study Procedures – Registry Group After your Treadmill Stress Test, approximately 2-3 tablespoons of blood will be collected for a Biomarker assessment. This is described later in this consent form. As part of the Registry Group, you will receive a phone call at years 1, 2, 3 and 5 to see how you are doing and ask if you have had any treatment to your aortic valve. No other procedures or assessments will be performed.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.