The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis.
This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3/SAPIEN 3 Ultra THV or Clinical Surveillance.
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• 65 years of age or older at time of randomization
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• Moderate aortic stenosis
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• Subject has symptoms or evidence of cardiac damage/dysfunction
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• The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
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• Native aortic annulus size unsuitable for the THV
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• Anatomical characteristics that would preclude safe placement of the introducer sheath or safe passage of the delivery system
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• Aortic valve is unicuspid or non-calcified
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• Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
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• Pre-existing mechanical or bioprosthetic aortic valve
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• Severe aortic regurgitation
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• Prior balloon aortic valvuloplasty to treat severe AS
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• LVEF < 20%
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• Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
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• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
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• Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
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Pathological Conditions, Anatomical
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Transcatheter aortic valve replacement (TAVR)
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Transcatheter heart valve
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Ventricular Outflow Obstruction
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