The participants in this study will receive the Edwards SAPIEN 3 transcatheter heart valve replacement (THV) study device. The procedure is referred to as TAVR, or “transcatheter aortic valve replacement.” The device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) for patients that have a low risk for complications from surgery. TAVR and the SAPIEN 3 device are FDA-approved for patients who have a high operative risk. However, the FDA is still studying the data on safety and efficacy of TAVR and SAPIEN 3 in low-risk patients and has not yet approved it for these patients. For such patients, the standard method of valve replacement includes open-heart surgery (referred to as “SAVR”—for “surgical aortic valve replacement”).
This study will help provide more data on TAVR in low-risk patients, as well as provide continued access to this procedure while it is still investigational. Your study doctor and staff will explain the risks and potential benefits of TAVR and the standard options open to you. This information is also presented later in this consent form.
The Edwards SAPIEN 3 THV Model 9600TFX study device (S3) is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart.
The study device SAPIEN 3 THV with the Commander Delivery System will be implanted transfemorally (through an artery in the leg). Through this route, the study device is delivered by means of a catheter (a long, thin, bendable tube that is placed in a blood vessel) in your leg and then maneuvered through the arteries in your leg leading to your heart to expand (open) your diseased aortic valve.
The study doctor performing the procedure may have limited experience with this technology, but has received extensive training by experienced study doctors who have implanted the study device in patients in the United States, Europe and/or Canada, and by the manufacturer of the study device, Edwards Lifesciences LLC. The risks for the study device and the procedure are listed in the Risk section.