About the EXPAND TAVR II Pivotal Trial

The purpose of this clinical trial is to collect information to observe the safety and effectiveness of transcatheter aortic valve replacement (TAVR) in moderate, symptomatic aortic stenosis condition and before aortic stenosis becomes severe.

The TAVR valve that will be studied in this trial has only been approved for use in the patients with severe, symptomatic aortic stenosis. The TAVR valve is investigational for people with moderate, symptomatic aortic stenosis condition.

View important safety information regarding the commercial TAVR device used in the trial by visiting the Important Safety Information link.

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Purpose of the EXPAND TAVR II Pivotal Trial

The purpose of this research trial is to explore the treatment of moderate, symptomatic aortic stenosis with TAVR before aortic stenosis becomes severe.

The TAVR valve that is used in this trial is approved as safe and effective treatment for use in severe, symptomatic aortic stenosis condition only. The TAVR valve is investigational for people with moderate, symptomatic aortic stenosis.

If you decide to participate in this study, you will be randomized to either TAVR (with guideline-directed management and therapy [GDMT]) or GDMT. You and your doctor will not be able to choose which treatment you receive.

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Participating in the EXPAND TAVR II Pivotal Trial

Participation in the trial includes the following steps:

  1. You will be given information about the trial and will be required to sign a consent form for participation.
  2. Assuming you meet the criteria to participate in the trial, you will be randomized to receive either TAVR (with GDMT) or GDMT.
  3. You will be required to participate in follow-up assessments. Your study doctor will schedule follow-up visits with you at 30 days, six months, one year, 18 months, and annually through 10 years following your treatment assignment. You will receive an echocardiogram evaluation at these visits so your valve and heart function can be evaluated. You must make every attempt to attend each visit as scheduled to complete all study-related assessments discussed in the study consent form.

Note: Testing and services done only for the study will be provided at no cost to you. These costs will not be billed to your health insurer or Medicare. You or your health insurer or Medicare will be responsible for all costs that are part of your normal medical care. You should discuss all costs with your doctor or nurse before agreeing to participate in the study.

Clinical trial locations

View details about locations for the EXPAND TAVR II Pivotal Trial by visiting the clinicaltrials.gov trial website.

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What is moderate, symptomatic aortic stenosis?

Aortic stenosis is a progressive disease, which means it tends to get worse over time. Because of this, doctors will typically measure aortic stenosis as mild, moderate, or severe. Aortic stenosis is a medical condition in which the opening of the aortic valve is narrowed, and therefore forces your heart to work harder to pump blood to the rest of your body. Over time, the extra work required by your heart can weaken the heart muscle and may affect your health and limit your normal daily activities. Your doctor has determined that you have moderate, symptomatic aortic stenosis and they can tell you more about why your aortic stenosis is categorized as moderate.

What is transcatheter aortic valve replacement (TAVR)?

TAVR is a treatment to replace your natural valve with an artificial valve that is made from pig tissue supported by a metal frame. The artificial valve is designed to work just like a healthy natural valve, opening and closing with each heartbeat.

TAVR has been studied and is approved as a safe and effective treatment for severe, symptomatic aortic stenosis but has not been approved for moderate, symptomatic aortic stenosis.

What is guideline-directed management and therapy?

Currently, the standard treatment for patients with moderate, symptomatic aortic stenosis is medical management therapy, including periodic tests and close observation. Your doctor will manage your medications including, but not limited to, high blood pressure and heart failure in accordance with GDMT.

If you are assigned to GDMT, the degree of your aortic stenosis may progress, and your doctor may determine that your condition requires TAVR or surgical valve replacement.

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 is indicated for patients with severe symptomatic aortic stenosis. This animation depicts a standard 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), or the 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 device that is part of the EXPAND TAVR II Pivotal Trial.