What is the Purpose of this Study?
The purpose of this study is to learn whether the SAPIEN 3 and SAPIEN 3 Ultra, and SAPIEN Ultra RESILIA Transcatheter Heart Valve are beneficial for patients with moderate, calcific aortic stenosis. Study procedures include transcatheter aortic valve replacement procedure and clinic visits. The SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA system include an artificial heart valve and accessories used to implant the valve, which will replace the patient’s valve. The artificial valve is made of 2 parts: a stent and valve leaflets. The stent (a metal mesh tube) holds the valve in position, and valve leaflets (made of cow tissue) open and close fully to direct the flow of blood through the heart.
Eligibility
- 1. 65 years of age or older at time of randomization
- 2. Moderate aortic stenosis
- 3. Subject has symptoms or evidence of cardiac damage/dysfunction
- 4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
The PROGRESS Trial Continued Access v1.0