Medtronic

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Caution: Investigational device. Limited by United States law to investigational use.

Frequently Asked Questions

What is severe is aortic stenosis?

How is severe aortic stenosis treated?

What is transcatheter aortic valve implantation (TAVI) and how does it work?

How much does the trial cost?

Will I be paid to participate?

How does the clinical trial operate?

How do I know if I’m eligible to participate?

What additional testing and screening are required to determine my eligibility?

Where can I get more information?

What is severe aortic stenosis?

The Heart
A healthy heart beats about 100,000 times a day and pumps about five quarts of blood each minute, or 75 gallons (284 liters) every hour. A normal heart has four chambers. The upper two chambers are the right and left atria. The lower two chambers are the right and left ventricles. The heart’s job is to supply the body with oxygen-rich blood. Blood is pumped through the four chambers with the help of four heart valves—the tricuspid, pulmonary, mitral and aortic valves.

The aortic valve directs blood from the left ventricle into the aorta. The aorta is the major blood vessel that leads from the left ventricle out to the rest of the body.

Severe Aortic Stenosis
Severe aortic stenosis occurs when the aortic valve doesn’t open or close properly. This forces your heart to work harder to pump blood throughout your body. Over time, the heart muscle weakens. This affects your overall health and keeps you from doing normal daily activities. If left untreated, severe aortic stenosis is a very serious, life-threatening condition, which may lead to heart failure and increased risk for sudden cardiac death.

Severe aortic stenosis is often not preventable and may be related to age; buildup of calcium deposits on the aortic valve (stenosis), which causes narrowing; radiation therapy; medications; a history of rheumatic fever; or high cholesterol.

Signs and symptoms of severe aortic stenosis can include:

  • Chest pain or tightness
  • Feeling faint or fainting with activity
  • Dizziness
  • Fatigue
  • Shortness of breath
  • Heart palpitations
  • Heart murmur

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How is severe aortic stenosis treated?

There are a number of treatments for certain patients with severe aortic stenosis. Because each patient has a different medical history, this information cannot replace discussions with your doctor. Please talk with your doctor about which treatment is best for you.

Medical Management
Medicines for severe aortic stenosis focus on treating problems that can occur as a result of your diseased aortic heart valve. For example, patients with severe aortic stenosis may take medicines to help control irregular heartbeats or prevent blood clots. These medicines may help control your symptoms for a period of time; however, without aortic valve replacement, severe aortic stenosis could worsen to a more serious condition.

Balloon Valvuloplasty
In addition to medications, and if your doctor recommends it, a procedure called Balloon Valvuloplasty may be performed to open the narrowed valve. It is a minimally-invasive, nonsurgical procedure that is performed by placing a balloon into the valve and inflating the balloon. A thin flexible tube (catheter) is first inserted through an artery in the groin or arm and guided to the heart. Once the tube reaches the narrowed aortic valve, the balloon is quickly inflated. The balloon presses against the narrowed valve, helping the valve open to allow more blood to flow through the heart. This procedure does not require open heart surgery.

Open Heart, Surgical Valve Replacement
Open heart aortic valve replacement surgery is an effective, life-saving treatment option for certain people with severe aortic stenosis. With open heart aortic valve replacement, your chest is opened to allow the surgeon access to your heart.

The operation varies from patient to patient, lasting about two hours and often longer. You are asleep for the operation. During the operation, the surgeon will remove any tissue and calcium deposits that are affecting the normal function of the valve. Your damaged valve may be completely removed. Then, the new valve will be sewn into the space where your own valve used to be. After the surgeon makes sure your valve is working properly, your heart will begin to pump blood and your chest will be closed.

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What is transcatheter aortic valve implantation (TAVI) and how does it work?

Transcatheter aortic valve implantation using the device being studied is only available through the clinical trial. With transcatheter aortic valve implantation, an artificial aortic heart valve is attached to a wire frame and guided by catheter (thin, flexible tube) to the heart. Once in the proper position in the heart, the wire frame expands, allowing the new aortic valve to open and begin to pump blood.

Talk with your doctor about potential risks associated with transcatheter aortic valve implantation.

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How much does the trial cost?

You should discuss the estimate of costs with your study doctor. You will not be charged for the cost of collecting the data for this study and other clinic visits and diagnostic tests done solely for the purposes of this study.

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Will I be paid to participate?

You will not be paid to participate in this clinical trial. You may be repaid for reasonable trial-related travel expenses. You will not be repaid for expenses for other family members.

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How does the clinical trial operate?

The clinical trial will involve more than 1,300 patients at approximately 40 hospitals in the United States. Before taking part in the clinical trial, you will need to obtain and sign a consent form at one of the U.S. hospitals in the trial. If you take part in the trial, you may be assigned to receive one of two treatments:

  1. Open heart surgical aortic valve replacement
  2. Transcatheter aortic valve implantation

Depending on your condition, you may be put in a treatment group that will be randomized.

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How do I know if I am eligible to participate?

Patients with severe aortic stenosis who are at high risk or at very high risk for standard open heart surgery may qualify to take part in the clinical trial. If chosen for the trial, more testing is done to determine eligibility. In a randomized trial, patients will learn if they will receive transcatheter aortic valve implantation only after they have first been enrolled in the clinical trial and then assigned for one of the treatments in the trial. Only your doctor can decide if you are a good candidate for the clinical trial.

Note: There is no age limitation for the clinical trial, however most patients are 75 years or older.

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What additional testing and screening are required to determine my eligibility?

Prior to taking part in the clinical trial, patients must go through tests and evaluations including: a standard physical examination, routine laboratory tests, electrocardiogram (EKG) and catheterization.

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Where can I get more information?

Learn more about the investigational therapy and the associated clinical trial. To see if you may qualify for this clinical trial, please take this short survey or connect with a participating doctor.

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