650
Participants
Start Date
April 27, 2022
Primary Completion Date
February 28, 2026
Study Completion Date
December 31, 2034
Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
Allgemeines Krankenhaus - Universitätskliniken Wien, Vienna
The Alfred Hospital, Melbourne
Inselspital - Universitätsspital Bern, Bern
Erasmus MC, Rotterdam
University Hospital Sankt Poelten, Sankt Pölten
St Antonius Ziekenhuis, Nieuwegein
CHU de Liege- Hopital du Sart Tilman, Liège
Fiona Stanley Hospital, Murdoch
The Mount Sinai Hospital, New York
Northwell Health, Manhasset
UPMC Pinnacle Harrisburg Campus, Harrisburg
Lehigh Valley Hospital, Inc, Allentown
Hospital of the University of Pennsylvania, Philadelphia
MedStar Washington Hospital Center, Washington D.C.
IRCCS Policlinico San Donato, San Donato Milanese
Ospedale San Raffaele - Milano, Milan
The Johns Hopkins Hospital, Baltimore
Skanes Universitetssjukhus, Lund
Carilion Roanoke Memorial Hospital, Roanoke
West Virginia University, Morgantown
Wake Forest University Heatlh Sciences, Winston-Salem
Hospital Universitario Ramón y Cajal, Madrid
Mission Hospital, Asheville
CHRU Brest - Hôpital de la Cavale Blanche, Brest
Saint Vincent's Medical Center Riverside, Jacksonville
University of Florida, Gainesville
Orlando Health, Orlando
Tampa General Hospital, Tampa
Morton Plant Hospital, Clearwater
University of Alabama at Birmingham (UAB) Hospital, Birmingham
Complejo Asistencial Universitario de Salamanca, Salamanca
Erlanger Medical Center, Chattanooga
Jewish Hospital, Louisville
The Ohio State University Wexner Medical Center, Columbus
Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund, Dortmund
Cleveland Clinic, Cleveland
Kettering Health Main Campus, Kettering
Hospital Clínico Universitario de Valladolid, Valladolid
Ascension Saint John Hospital, Detroit
Rabin Medical Center- Beilinson Hospital, Petah Tikva
Spectrum Health, Grand Rapids
Aurora Saint Lukes Medical Center, Milwaukee
Universitätsklinikum Bonn, Bonn
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz
Abbott Northwestern Hospital, Minneapolis
Mayo Clinic, Rochester
Monument Health Rapid City Hospital, Rapid City
SSM Health Saint Louis University Hospital, St Louis
Terrebonne General Medical Center, Houma
Integris Baptist Medical Center, Oklahoma City
Institut Mutualiste Montsouris, Paris
Hôpital Européen Georges Pompidou, Paris
Medical City Dallas, Dallas
Texas Health Harris Methodist Hospital Fort Worth, Fort Worth
Houston Methodist Hospital, Houston
Methodist Hospital San Antonio, San Antonio
Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen
University of Colorado Hospital, Aurora
Intermountain Cardiovascular and Thoracic Surgery, Salt Lake City
Abrazo Arizone Heart Hospital, Phoenix
HonorHealth Scottsdale Shea Medical Center, Scottsdale
Los Robles Hospital & Medical Center, Thousand Oaks
Presidio Ospedaliero Gaspare Rodolico, Catania
Oregon Health & Science University Hospital, Portland
Providence Sacred Heart Medical Center & Children's Hospital, Spokane
Shaare Zedek Medical Center, Jerusalem
Saint Vincents Medical Center, Bridgeport
Hartford Hospital, Hartford
Tallahassee Memorial Hospital, Tallahassee
Tufts Medical Center, Boston
Beth Israel Deaconess Medical Center, Boston
Baystate Medical Center, Springfield
University of Michigan Health System - University Hospital, Ann Arbor
Catholic Medical Center, Manchester
Deborah Heart and Lung Center, Browns Mills
Englewood Hospital & Medical Center, Englewood
University Hospitals Cleveland Medical Center, Cleveland
The University of Vermont, Burlington
Sunnybrook Health Sciences Centre, Toronto
Montreal Heart Hospital, Montreal
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Québec
Queen Elizabeth II Health Sciences Centre, Halifax
CHU de Rennes - Hôpital Pontchaillou, Rennes
Hôpital de la Timone, Marseille
Catharina Ziekenhuis, Eindhoven
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied, Clermont-Ferrand
Herzzentrum Leipzig GmbH, Leipzig
Klinikum der Universität München - Campus Grosshadern, München
Galway University Hospitals - University Hospital Galway (UHG), Galway
Shonan Kamakura General Hospital, Kanagawa
Tokai University Hospital, Isehara
Kawasaki Saiwai Hospital, Kawasaki
Osaka Keisatsu Hospital, Osaka
Osaka University Hospital, Osaka
Universitair Medisch Centrum Groningen, Groningen
Hospital Universitari Clínic de Barcelona, Barcelona
Saint Bartholomew's Hospital, London
Lead Sponsor
Medtronic Cardiovascular
INDUSTRY