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SAPIEN 3 Ultra Post Market Registry
Study to Collect Information on SAPIEN 3 Ultra Transcatheter Heart Valve
Sponsor:Edwards Lifesciences
Enrolling:Male and Female Patients
Minimum Age:18 years old
IRB Number:AAAS9117
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information:

This is a prospective, single-arm, observational, multicenter registry. The intent is to gather information on the commercially approved device, device SAPIEN 3 Ultra transcatheter heart valve (THV). This valve consists of a short metal tube (stent) that holds the valve in its intended position and has valve leaflets made of biological material derived from cows to direct the flow of blood through the heart the way a normal valve would if it was healthy. This artificial valve is delivered into the heart by a small flexible tube (catheter) that is about as big around as a pencil. This flexible tube is placed in a blood vessel in the leg, and then threaded through the blood vessels to the opening of the heart the aortic heart valve. The SAPIEN 3 Ultra Transcatheter Valve, will be carefully positioned and placed across the diseased heart valve to begin controlling the flow of blood though the heart. Data collected will be used to evaluate various hemodynamic (blood flow) performance measures associated with the SAPIEN 3 Ultra Transcatheter Valve. This will be done by collecting and reviewing echocardiographic imaging assessments, which is done as part of standard of care during and after the valve replacement procedures. The study will enroll up to 200 subjects who undergo transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 Ultra System and receive and retain the study valve upon leaving the procedure room. Enrollment will be across at 10 US Sites. Clinical data and imaging available from routine clinical assessments will be available from routine clinical assessments and will be collected from pre-procedure through 1-year post-procedure.

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Who Can I Contact?
For more information, please contact:
Kate Dalton
Email: keb2114@cumc.columbia.edu
Phone: 347-514-3366