Patients and care partners
Now enrolling
The purpose of the PROGRESS CAP study is to allow patients with moderate, calcific aortic stenosis access to transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 transcatheter heart valve family.
By participating in this study, you may be able to help researchers while helping others like yourself.
Contact our Patient Support Center to find a participating hospital near you.
Gender and ethnic differences matter in the selection process as some conditions are more prevalent in certain groups. No matter who you are, please consider participating to see if you qualify.
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.
Symptoms can include:
Talk to your doctor about the PROGRESS CAP study 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 study.
Based on current evidence, some patients with moderate aortic
stenosis and added risk factors may benefit from having their aortic valve replaced before they progress to severe aortic stenosis.
The PROGRESS CAP study will allow patients with moderate, calcific aortic stenosis access to TAVR with the study valves.
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 study, visit NCT04889872 at Clinical Trials.gov.
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CAUTION: INVESTIGATIONAL DEVICES. Limited by Federal (USA) law to investigational use only. The Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA transcatheter heart valves are investigational devices when used in patients with moderate, calcific aortic stenosis. These devices are not available for marketing or commercial sale in the United States for patients with moderate aortic stenosis.