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Low Risk Main Randomized Trial has been closed to enrollment.
Bicuspid Registry - Currently Enrolling:
To assess the safety and effectiveness of the SAPIEN 3 Edwards Valve in patients who are low risk for open heart surgery and have been diagnosed with severe aortic stenosis and a bicuspid aortic valve can be enrolled into a non-randomized registry and undergo a TAVR procedure.
Aortic Valve-in-Valve Registry - Currently Enrolling:
To assess the safety and effectiveness of the SAPIEN 3 Edwards valve in patients with a failing aortic bioprosthetic valve.
Bicuspid Registry
Inclusion:
-Deemed low risk by surgeon
-Severe aortic stenosis
-Bicuspid aortic valve
-Subject is informed and agrees to study provisions and has provided informed consent as approved by the IRB
Exclusion:
-Tricuspid aortic valve
-Severe aortic or mitral regurgitation
-Aneurysmal ascending aorta >4.0cm
-Currently participating in an investigational drug or another device study
Aortic Valve-in-Valve Registry
Inclusion:
-Failing surgical or transcatheter bioprosthetic valve in the aortic position with >/= moderate stenosis and/or >/= moderate insufficiency
-Deemed low to intermediate risk by a surgeon
-Subject is informed and agrees to study provisions and has provided informed consent as approved by the IRB
Exclusion:
-Surgical or transcatheter valve in the mitral position
-Severe regurgitation or stenosis of any other valve
-Renal insufficiency
-Currently participating in an investigational drug or another device study
Upper East Side - Manhattan
Shing Chiu Wong, MD (UES)
Open to Enrollment
