The PROGRESS Trial - Continued Access Study Number: 2021-01-CAP

Brief description of study

The purpose of this study is to evaluate an investigational treatment for people with moderate, calcific aortic stenosis:

The SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA system includes an artificial heart valve and accessories used to implant the valve. The selection of the study device will be made at the discretion of your doctor.

The artificial valve is made of two 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 your heart.

Clinical Study Identifier: s24-00185

ClinicalTrials.gov Identifier: NCT04889872

Principal Investigator: Richard K Schwartz.

Other Investigators: Mohammed N Imam, Sunil Abrol.

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