This is a prospective, single arm, multicenter study in an cohort of up to 267 patients (up to 100 Roll-ins and 167 patients implanted per protocol) symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Male or Female
✓. Age ≥ 65 years at time of consent
✓. Women of non-childbearing potential
✓. Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:
✓. Aortic valve area (AVA) \< 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and
✓. Jet velocity \> 4.0 m/s or mean gradient \> 40 mmHg
✓. Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:
✓. Dyspnea that qualifies at NYHA class II or greater
Exclusion criteria
✕. Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves.
✕. Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation).
✕. Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation.
✕. Patient has a hypertrophic obstructive cardiomyopathy.
. History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed).
✕. Untreated clinically significant coronary artery disease requiring revascularization at the screening visit.
✕. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
✕. Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support