IRB Protocol #: 1601016864

Overview: To assess safety and efficacy of the Portico Valve in patients who are high or extreme risk for open heart surgery.

Patients must be:

 •      Assessed by surgeons and deemed either high or extreme risk for open heart surgery

 •      Severe, symptomatic aortic stenosis

 •      The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site

Patients cannot participate if they have:

 •      Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)

 •      Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects with pre-existing surgical bioprosthetic aortic heart valve should be considered for the Valve-in-Valve registry

 •      Life expectancy <12 months from the time of informed consent due to non-cardiac co-morbid condition 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO)