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Holland","2333",{"type":52,"coordinates":751},[752,753],4.49306,52.15833,{"lat":753,"lon":752},{"facility":756,"status":59,"city":757,"state":748,"zip":758,"country":738,"countryCode":739,"cosmosGeoPoint":759,"geoPoint":763,"contacts":18},"Erasmus Rotterdam","Rotterdam","3015",{"type":52,"coordinates":760},[761,762],4.47917,51.9225,{"lat":762,"lon":761},{"facility":765,"status":59,"city":766,"state":18,"zip":767,"country":768,"countryCode":769,"cosmosGeoPoint":770,"geoPoint":774,"contacts":18},"Hôpitaux Universitaire de Genève","Geneva","1205","Switzerland","CH",{"type":52,"coordinates":771},[772,773],6.14569,46.20222,{"lat":773,"lon":772},{"facility":776,"status":80,"city":777,"state":18,"zip":778,"country":768,"countryCode":769,"cosmosGeoPoint":779,"geoPoint":783,"contacts":18},"Universitätsspital Zürich","Zurich","8091",{"type":52,"coordinates":780},[781,782],8.55,47.36667,{"lat":782,"lon":781},{"type":785,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100430806","progress-management-of-moderate-aortic-stenosis-by-clinical-surveillance-or-tavr-100430806",false,"NCT04889872","PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR","The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement","PROGRESS","Key Inclusion Criteria:\n\n1. 65 years of age or older at time of randomization\n2. Moderate aortic stenosis\n3. Subject has symptoms or evidence of cardiac damage\u002Fdysfunction\n4. 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.\n\nKey Exclusion Criteria:\n\n1. Native aortic annulus size unsuitable for the THV\n2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system\n3. Aortic valve is unicuspid or non-calcified\n4. Bicuspid aortic valve with an aneurysmal ascending aorta \\> 4.5 cm or severe raphe\u002Fleaflet calcification\n5. Pre-existing mechanical or bioprosthetic aortic valve\n6. Severe aortic regurgitation\n7. Prior balloon aortic valvuloplasty to treat severe AS\n8. LVEF \\\u003C 20%\n9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR\n10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation\n11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR","ALL","65 Years",{"count":797,"type":798},2250,"ESTIMATED","INTERVENTIONAL",[801],"NA","This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 \u002F SAPIEN 3 Ultra \u002F SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis.\n\nFollowing completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.",[804,805],"Aortic Stenosis, Calcific","Aortic Valve Stenosis",[807,808,809,810,811,812,813],"Transcatheter aortic valve replacement (TAVR)","SAPIEN 3","SAPIEN 3 Ultra","SAPIEN 3 Ultra RESILIA","Moderate aortic stenosis","Aortic stenosis","Transcatheter heart valve","2025-12-12",{"date":816,"type":817},"2025-12-17","ACTUAL",{"date":819,"type":817},"2021-10-12",{"date":821,"type":798},"2037-06",{"name":5,"class":6},80]