The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is 18 years or older
✓. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
✓. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
✓. Surgery is intended to be completed with an EDWARDS INTUITY Elite Heart Valve.
✓. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
✓. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
Exclusion criteria
✕. Subject is diagnosed with pure aortic insufficiency.
✕. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
✕. Subject has severe ventricular dysfunction defined as LVEF \< 25%.
✕. Subject has a history of active endocarditis and/or myocarditis ≤ 3 months before the intended treatment/scheduled surgery.
✕. Subject has had an acute MI ≤ 3 months before the intended treatment.
✕. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.