The trial is designed to assess the safety and performance of a new approach to aortic valve replacement. The valve being studied has been developed for patients with severe aortic stenosis (AS). Please note as you read this, that if you decide to be a part of the trial, you are not guaranteed to receive the valve being studied. Discuss any questions you have with your doctor. Only a doctor can decide if you are a good candidate for participation in this clinical trial.
What is Aortic Stenosis?
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 AS occurs when the aortic valve doesn’t open 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 participating in normal daily activities. If left untreated, severe AS is a very serious, life-threatening condition, leading to heart failure and increased risk for sudden cardiac death.
Severe AS 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 AS can include:
• Chest pain or tightness
• Feeling faint or fainting with activity
• Shortness of breath
• Heart palpitations
• Heart murmur
How is severe aortic stenosis treated?
There are several established categories of treatments for certain patients with severe aortic stenosis.
Because each patient has a unique medical history, this information cannot replace discussions with your doctor. Please consult your doctor about which treatment is best for you.
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 Aortic 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.. Your surgery is performed while the function of your heart is taken over by a heart-lung machine (called CPB for cardiopulmonary bypass).
Immediately after the operation, you’ll probably be drowsy. You will spend the next few hours, or possibly the night, in the intensive care unit (ICU). When intensive care monitoring is no longer needed, you will be moved to a step-down unit and, when ready, to a regular hospital room. A typical hospital stay is 5-10 days.
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) through an artery from the groin area 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.
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.
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.
How is does the clinical trial operate?
The clinical trial will involve more than 1,000 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 three treatments:
• Medical management
• Open heart surgical aortic valve replacement
• Transcatheter aortic valve implantation
The treatment option patients receive will be decided on a random basis. This means that if you meet the criteria to be in the trial, you may be assigned to receive any of these three treatments.
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.
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.
Where can I get more information?
Please visit www.AorticStenosisTrial.com for more information regarding the CoreValve U.S. Pivotal Trial. Here you will find information regarding severe aortic stenosis, treatments for the disease and details about participating in the trial. You will also find a listing of the hospitals and physicians around the US authorized to help determine your eligibility.
Are there safeguards in place for research studies of investigational medical devices?
The United States government and, specifically, the Food and Drug Administration (FDA) have strict regulations and safeguards in place to protect people who choose to participate in clinical trials. Additionally, every clinical trial in the U.S. must be reviewed and approved by an Institutional Review Board (IRB). The purpose of an IRB is to protect the rights and safety of people who volunteer to take part in research studies. Before participating in a trial, a person must agree to sign an informed consent form, which provides detailed information about the study and study procedures. Experienced doctors who have been thoroughly trained are designated as investigators for the study. These investigators (doctors), who specialize in a specific condition or disease, administer the study procedures and closely monitor study participants. For more information on clinical research trials, visit www.clinicaltrials.gov.