Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Aortic Valve Stenosis, Structural Valve Deterioration
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Valve-In-Valve, Aortic stenosis, Aortic regurgitation, Trans-catheter aortic valve, Degenerated aortic valve
Eligibility Criteria
Inclusion Criteria: Patients meeting ALL the following criteria will be included: Patients aged ≥ 18 years. Severe haemodynamical valve deterioration of a biological aortic valve implanted surgically, including severe valve stenosis (effective aortic valve area < 1.0 cm2) and/or severe valve regurgitation. The patient has cardiac symptoms and/or deterioration of left ventricular ejection fraction attributable to the aortic valve disease. Heart team decision of VIV procedure. Patient is willing to return at 30 days for TTE and to be clinically contacted at 1 year. Exclusion Criteria: Patients meeting, at least, 1 of the following criteria will be excluded: Patients who openly express their refusal to participate in the study. Female patients in gestational age. Presence or suspicious of biological aortic valve thrombosis. Known hypersensitivity or contraindication to antithrombotic therapy (or inability to be anticoagulated during the procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated. Ongoing sepsis and/or suspicious or diagnosis of endocarditis. Patients whose life expectancy is < 1 year due to non-cardiac comorbid conditions. Medical, social, or psychological conditions that preclude the subject from appropriate consent or adherence to the protocol required follow-up exams. True inner diameter of the prosthetic valve > 27 mm. Transfemoral access inadequate to accommodate an 18F sheath. Patients included in other clinical trials (excluding registries).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
NVT ALLEGRA System TF
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
NVT ALLEGRA System TF
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM