About the Trial
The PROGRESS trial will examine the transcatheter aortic valve replacement (TAVR) procedure versus careful observation (or clinical surveillance) in patients with moderate aortic stenosis and at least one additional risk factor.
By participating in this trial, you may be able to help your doctors while helping others like yourself.
Contact our Patient Support Center to find a participating hospital near you
Why study moderate aortic stenosis?
Your heart has four valves that open and shut like doors to help pump blood throughout your body. One of the four valves is called the aortic valve. The tissue of the aortic valve’s leaflets can become stiff (due to a build-up of calcium), which causes the opening of the valve to become smaller and prevent it from opening and shutting properly. This condition is called aortic stenosis, and it affects 2.5 million people over the age of 75 in the United States.
As the opening becomes smaller, it makes it harder for the heart to pump blood, which can affect your health. Aortic stenosis is a progressive disease, meaning that the valve will get narrower and narrower, worsening over time. Slowly but surely this narrowing and increase of pressure will lead to additional cardiac problems.
Doctors will typically categorize cases of aortic stenosis as mild, moderate, or severe. The stage of aortic stenosis depends on how damaged your aortic valve is.
Disease Progression in Aortic Stenosis
Healthy
Mild
Moderate
Severe
Moderate aortic stenosis is a slightly advanced stage of the disease.
You may or may not notice symptoms.
Symptoms can include:
Chest pain
Shortness of
breath
Fatigue
Fatigue
Are you a candidate?
You may be eligible for this trial if you:
- are 65 years of age or older
- have moderate aortic stenosis and at least one additional risk factor
-
Have at least one risk factor:
-
Symptoms due to your diseased valve (e.g., chest pain, shortness of breath, fatigue, rapid heart rate)
-
Your heart muscle is not squeezing as much as normal
-
Stiffening of your heart muscle that does not allow your heart chambers to fill with blood like normal
-
A reduced amount of blood being pumped out of your heart with each heartbeat
-
Rapid or irregular beating of your heart
-
Abnormal blood test that measures how hard your heart is working
-
Certain findings on a Computed Tomography (CT) scan
Talk to your doctor about the PROGRESS trial and see if it is right for you.
Ask your doctor or research coordinator for the full list of criteria. If you choose to participate, you will be asked to complete health and imaging assessments to ensure you meet the criteria to continue in the clinical trial.
Questions to Ask Your Doctor
- Am I a candidate for the PROGRESS trial?
- What screening tests will be done?
- What is the recovery time for TAVR?
- What are the possible risks and benefits of the TAVR procedure?
- What are the possible risks and benefits of the TAVR procedure?
We’re here for you
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, or if you are interested in being part of this study, please contact the Edwards Patient Support Center. For details about the trial, visit NCT04889872 at Clinical Trials.gov.
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