All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Aortic Stenosis, Severe
About this trial
This is an interventional other trial for Aortic Stenosis, Severe
Eligibility Criteria
Inclusion Criteria: Female sex Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular heart disease) Severe calcific aortic valve stenosis defined as follows: high-gradient aortic stenosis (mean pressure gradient across aortic valve > 40 mmHg or peak velocity > 4.0 m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class ≥II ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic annulus perimeter-derived average diameter >19 mm and <27.4 mm or area-derived diameter >18 and <28 mm Anatomy suitable for trans-femoral TAVI for both devices used in the study, including a minimum femoral diameter of 6 mm. Subject with a documented local Heart Team (HT) indication for TF TAVI Life expectancy longer than 1 year. Willingness to undergo clinical and echocardiographic follow-up after the procedure. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow-up requirements Exclusion Criteria: Male sex Non-calcific acquired aortic stenosis Native unicuspid/bicuspid aortic valve or congenital aortic abnormality Previous implantation of heart valve in any position Severe aortic regurgitation (> 3+) Severe mitral regurgitation (> 3+) Severe tricuspid regurgitation (> 3+) Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) < 30%) Echocardiographic evidence of intracardiac mass, thrombus or vegetation Untreated cardiac conduction disease in need of pacemaker implantation Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed consent Any need for emergency surgery Any active bleeding that precludes anticoagulation Liver failure (Child-C) End-stage renal disease requiring chronic dialysis or creatinine clearance < 30cc/min Pulmonary hypertension (systolic pressure > 80mmHg) A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to cobalt chromium, to bovine and/or collagen, glutaraldehyde or contrast media Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow-up procedures Currently participating in another drug or device trial (excluding observational registries) for which the primary endpoint has not been assessed Subject under judicial protection, tutorship or curatorship (for France only)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ALLEGRA
Balloon-expandable TAVI
ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care
Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care