This website provides information for patients who are considering participation in the SMART Clinical Trial. Please contact your healthcare provider for more information.
This material is provided strictly to patients identified for participation in the SMART Trial.
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.
The SMART Trial is a research study to compare the safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in patients with a small aortic valve.
You have been identified by your doctor as a patient who is eligible to participate in the SMART Trial. Discuss any questions you may have with your doctor.
If you decide to participate in this study, the TAVR system you receive will be determined randomly. You and your doctor will not be able to choose which TAVR system you receive.
Additional information about the SMART Trial can be found on ClinicalTrials.gov.
A healthy heart beats approximately 100,000 times per day. The heart's job is to supply the body with oxygen-rich blood. The heart has four chambers. Blood is pumped through the four chambers with the help of four heart valves. Severe aortic stenosis occurs when your aortic valve does not open as it should. This makes your heart work harder to pump blood through your body. This affects your health and limits your normal daily activities.
TAVR is less invasive than open-heart surgery. Your doctor will make a small incision on your body. Then, a thin, flexible tube is inserted into an artery to guide the artificial heart valve to your heart to replace the diseased valve.
The aortic valve controls blood flow to the body (except the lungs).
As with any medical procedure, there is a possibility of risks.
The most serious risks associated with the TAVR procedure include:
The chance of an adverse event from the TAVR procedure depends on many factors, including your underlying medical conditions.
Additional potential risks associated with the procedure:
In addition, you may experience other problems that have not been previously observed with this procedure.
Ask your doctor if you have any questions related to the potential benefits and risks associated with the TAVR procedure, or if you would like additional information related to the TAV devices that are part of the SMART Trial.
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