Transfemoral Implant of Inovare® Transcatheter Valve

Inclusion Criteria: * Calcified degenerative aortic stenosis with valve area \< 1.0 cm2 (or valve area index \< 0.6 cm2/m2) and mean transvalvular gradient \> 40 mmHg or aortic jet velocity \> 4 m/s by echocardiogram. * Multidisciplinary evaluation by the "Heart Team", composed of a cardiovascular surgeon, clinical cardiologist and hemodynamicist, which concludes that the patient has: * High surgical risk for aortic valve replacement, typically with an STS score of ≥ 8% (or logistic EuroSCORE ≥ 20%) or intermediate risk (STS of ≥ 3% and \< 8%); * Presence of porcelain aorta or hostile chest, as well as global clinical condition and comorbidities not fully addressed by the score STS * Presence of extreme frailty (5-meter walk test \[5MWT\], grip strength, activities of daily living (ADL), and albumin laboratory exam); * Considerable chance of clinical benefit with the transcatheter procedure. * Heart failure symptoms NYHA functional ≥ II. * Aortic valve annulus with a mean diameter between 17.3 and 28.6 mm, documented by imaging method, suitable for positioning and accommodation of the Inovare® prosthesis, according to the judgment of an experienced hemodynamicist. * Height of coronary ostia \> 10 mm or presence of a coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after valve release. * Femoral arterial access route considered adequate for the progression of the vascular introducer and prosthesis-balloon system, typically evaluated through multi-imaging methods that include, for example, conventional angiography and computed tomography. * Patient has provided written informed consent to participate in the trial. Exclusion Criteria: Clinic * Hemodynamic instability requiring vasoactive drugs or circulatory support; * Valve procedure with clinical need to be performed in a time of urgency or emergency (non-elective); * Left ventricular ejection fraction \< 30%; * Chronic renal failure on dialysis or with serum creatinine levels \> 3.0 mg/dL (265 µmol/L); * Acute renal failure with serum creatinine that has not yet returned to baseline levels; * Clinical or biological signs of infection with systemic repercussions; * Endocarditis \< 12 months; * Coronary artery disease requiring elective revascularization during or after the valve procedure; * Evidence of myocardial infarction in an interval of less than one month; * Recent stroke or transient ischemic attack (within the last 6 months); * Hypersensitivity or contraindication to the administration of heparin, ticlopidine or clopidogrel or to radiopaque contrast; * Anemia (hemoglobin \< 10 g/dl), thrombocytopenia (\< 100,000 cells/mm3) or hyperthrombocytosis (\> 700,000 cells/mm3); * Need for chronic anticoagulation for other causes; * Active peptic disease, gastrointestinal bleeding \< 3 months, or previously diagnosed bleeding diathesis; * Life expectancy less than 12 months due to non-cardiac disease or other comorbidities. Anatomical/morphological * Valve ring diameter less than or equal to 17.2 mm or greater than or equal to 28.7 mm; * Iliofemoral access route, with extreme tortuosity or calcification or reduced luminal diameter (typically \< 7 mm), which prevents safe progression of the arterial introducer and delivery system with the prosthesis, according to the judgment of the responsible physician; * Presence of sessile and unstable atheromas in the ascending aorta and/or aortic arch detected by imaging methods; * Obstructive hypertrophic cardiomyopathy or severe left ventricular outflow tract obstruction, with no possibility of balloon dilation; * Previous aortic or mitral valve procedure (surgical or by catheter, excluding aortic balloon valvuloplasty); * Moderate or severe aortic, mitral or tricuspid regurgitation; * Non-calcified native valve; * Evidence of an intracardiac mass (tumor, thrombus, or vegetation).