About The SMART Trial

Attention

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.

What is the SMART Trial?

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.

Clinical Trial Locations

Clinical trial locations

For details about locations for the SMART Trial, visit the trial website.

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What is Aortic Stenosis?

What is Severe Aortic Stenosis?

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.

What is Transcatheter Aortic Valve Replacement (TAVR)?

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.

Illustration of heart and chambers where aortic valve is shown

The aortic valve controls blood flow to the body (except the lungs).

The TAVR Procedure

TAVR Procedure Risks

As with any medical procedure, there is a possibility of risks.

The most serious risks associated with the TAVR procedure include:

  • Death
  • Stroke
  • Serious damage to the arteries
  • Serious bleeding — a bleeding event that requires a blood transfusion
  • Need for permanent pacemaker

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:

  • Heart attack
  • Cardiogenic shock — failure of the heart to pump enough blood to the body organs
  • Cardiac tamponade — the constriction or inability of the heart to pump due to buildup of blood or fluid around the lining of the heart
  • Infection in your heart, blood, or other areas
  • Blood clot, including a blood clot on the valve
  • Additional cardiac surgery, vascular surgery, or intervention, including removal of the TAV
  • Problems with the valve or accessories that do not allow it to work well, including but not limited to:
    • Wear, tear, or movement forward (prolapse) or backward (retraction) from the normal position of the valve leaflets
    • Break (fracture) in the valve frame
    • Incorrect position of valve or valve movement
    • Buildup of calcium on the valve
    • Leakage through or around the valve or valve frame
    • Bending of the valve frame
    • Valve frame does not open (expand) all the way
    • Pannus — the formation of scar tissue that may cover or block the valve from functioning normally
    • A break in the stitches (sutures) of the valve frame or leaflets
    • Regurgitation — backward flow of blood through the valve
    • Incorrect size of the valve implanted
    • Stenosis — narrowing of the opening of the valve
  • Injury to your blood vessels or heart that requires treatment
  • Partial or complete block of coronary artery (that supplies blood to the heart)
  • Lab values that are not normal
  • Hypotension or hypertension — abnormally high or low blood pressure
  • Embolism — an abnormal particle (air, blood clots) floating in the blood stream or attached to an object, including the valve or delivery system component
  • Damage to blood cells
  • Individual or multi-organ insufficiency or failure
  • Injury to nerve
  • Permanent disability
  • Allergic reaction
  • Pain, bleeding, or other complications at the incision site
  • Blocking, narrowing, or bulging of a blood vessel
  • Prolonged procedure time
  • Exposure to radiation
  • Bowel ischemia — decreased blood supply to the intestines
  • Mitral valve regurgitation — blood leaking backward through the valve between the left lower chamber of the heart to the left upper chamber of the heart
  • Perforation of the myocardium or vessel — a hole in the heart muscle or a blood vessel
  • Irregular heart rate
  • Fainting or dizziness
  • Repeat hospitalization
  • Weakness or trouble exercising
  • Extra or unusual sound during heartbeat (heart murmur)
  • Trouble or inability to breathe
  • Fluid buildup in your lungs
  • Anemia
  • Chest pain
  • Inability to move (paralysis)
  • Pain, inflammation, or fever
  • Sudden or unexpected loss of heart function

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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