1,948
Participants
Start Date
June 10, 2019
Primary Completion Date
June 14, 2024
Study Completion Date
September 30, 2034
ACURATE neo2™ Transfemoral TAVR System
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Medtronic CoreValve TAVR System
Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
Edwards SAPIEN 3 TAVR System
Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
ACURATE Prime™ Transfemoral TAVR System XL
ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Mount Sinai Medical Center, New York
Columbia University Medical Center/NYPH, New York
Cornell Presbyterian - New York, New York
Montefiore-Jack D. Weiler Hospital, The Bronx
Albany Medical Center, Albany
Kaleida Health, Buffalo
UPMC Pittsburgh, Pittsburgh
UPMC - Pinnacle, Harrisburg
WellSpan York Hospital, York
Lankenau, Wynnewood
MedStar Washington Hospital Center, Washington D.C.
Union Memorial Hospital, Baltimore
University of Virginia Health System, Charlottesville
Sentara Norfolk General Hospital, Norfolk
Wake Forest University School of Medicine, Winston-Salem
University of North Carolina, Chapel Hill
Carolinas Medical Center, Charlotte
Lexington Medical Center, West Columbia
Medical University of South Carolina, Charleston
Piedmont Hospital, Atlanta
Orlando Regional Medical Center, Orlando
Morton Plant Hospital, Clearwater
University of Alabama at Birmingham, Birmingham
St Thomas Ascension, Nashville
OhioHealth Research and Innovation Institute, Columbus
University Hospitals of Cleveland, Cleveland
Cleveland Clinic, Cleveland
Lindner Center for Research and Education at Christ Hospital, Cincinnati
St. Vincent's Hospital, Indianapolis
University of Michigan, Ann Arbor
Henry Ford Hospital, Detroit
University of Iowa, Iowa City
Aurora Research Institute, Milwaukee
Medical College of Wisconsin - Froedtert Hospital, Milwaukee
Bellin Health, Green Bay
St. Joseph's Hospital-St. Paul, Saint Paul
Abbott Northwestern Hospital, Minneapolis
CentraCare Heart and Vascular Center, Saint Cloud
NorthShore University Health Study Coordinator, Evanston
Advocate Christ Medical Center, Oak Lawn
St. John's Hospital (Prairie), Springfield
Baptist Health Medical Center, Little Rock
Integris Baptist Medical Center, Oklahoma City
Baylor Regional Medical Center at Plano, Plano
Baylor Heart and Vascular Hospital, Dallas
Presbyterian Hospital of Dallas, Dallas
The Methodist Hospital Research Institute, Houston
The University of Texas Health Science Center at Houston, Houston
Methodist Healthcare System of San Antonio dba Methodist Hospital, San Antonio
Austin Heart, Austin
Banner Good Samaritan, Phoenix
HonorHealth Scottsdale Healthcare, Scottsdale
TMC HealthCare, Tucson
Kaiser Permanente Los Angeles, Los Angeles
Cedars-Sinai Heart Institute, Los Angeles
Scripps Clinic, La Jolla
Kaiser Permanente - San Francisco, San Francisco
Stanford University Medical Center, Stanford
University of California, Davis Medical Center, Sacramento
Providence Heart Institute, Portland
Sacred Heart Medical Center - Riverbend, Springfield
Providence Regional Medical Center, Everett
Massachusetts General Hospital, Boston
Brigham and Women's Hospital, Boston
University of Massachusetts, Worcester
Deborah Heart and Lung Center, Browns Mills
Englewood Health, Englewood
Robert Wood Johnson Medical Center, New Brunswick
The University of Vermont Medical Center, Burlington
Royal Columbian Hospital, New Westminster
Providence Health - St. Paul's Hospital, Vancouver
London Health Sciences, London
Sunnybrook Health Sciences Centre, Toronto
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ), Québec
Lead Sponsor
Boston Scientific Corporation
INDUSTRY