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ACTIVE NOT RECRUITING
NCT05149755
NA

Evolut™ EXPAND TAVR II Pivotal Trial

Sponsor: Medtronic Cardiovascular

View on ClinicalTrials.gov

Summary

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

650

Start Date

2022-04-27

Completion Date

2034-12

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DEVICE

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).

Locations (94)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, United States

Abrazo Arizone Heart Hospital

Phoenix, Arizona, United States

HonorHealth Scottsdale Shea Medical Center

Scottsdale, Arizona, United States

Los Robles Hospital & Medical Center

Thousand Oaks, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Saint Vincents Medical Center

Bridgeport, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Morton Plant Hospital

Clearwater, Florida, United States

University of Florida

Gainesville, Florida, United States

Saint Vincent's Medical Center Riverside

Jacksonville, Florida, United States

Orlando Health

Orlando, Florida, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Jewish Hospital

Louisville, Kentucky, United States

Terrebonne General Medical Center

Houma, Louisiana, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Baystate Medical Center

Springfield, Massachusetts, United States

University of Michigan Health System - University Hospital

Ann Arbor, Michigan, United States

Ascension Saint John Hospital

Detroit, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

SSM Health Saint Louis University Hospital

St Louis, Missouri, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Englewood Hospital & Medical Center

Englewood, New Jersey, United States

Northwell Health

Manhasset, New York, United States

The Mount Sinai Hospital

New York, New York, United States

Mission Hospital

Asheville, North Carolina, United States

Wake Forest University Heatlh Sciences

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Kettering Health Main Campus

Kettering, Ohio, United States

Oregon Health & Science University Hospital

Portland, Oregon, United States

Lehigh Valley Hospital, Inc

Allentown, Pennsylvania, United States

UPMC Pinnacle Harrisburg Campus

Harrisburg, Pennsylvania, United States

Monument Health Rapid City Hospital

Rapid City, South Dakota, United States

Erlanger Medical Center

Chattanooga, Tennessee, United States

Medical City Dallas

Dallas, Texas, United States

Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Methodist Hospital San Antonio

San Antonio, Texas, United States

Intermountain Cardiovascular and Thoracic Surgery

Salt Lake City, Utah, United States

The University of Vermont

Burlington, Vermont, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Aurora Saint Lukes Medical Center

Milwaukee, Wisconsin, United States

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Australia

University Hospital Sankt Poelten

Sankt Pölten, Austria, Austria

Allgemeines Krankenhaus - Universitätskliniken Wien

Vienna, Austria

CHU de Liege- Hopital du Sart Tilman

Liège, Belgium

London Health Sciences Centre- University Campus

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Montreal Heart Hospital

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Canada

CHU de Rennes - Hôpital Pontchaillou

Rennes, Brittany Region, France

CHRU Brest - Hôpital de la Cavale Blanche

Brest, France

Institut Médico-Chirurgical Montsouris

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Universitätsklinikum Bonn

Bonn, Germany

Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund

Dortmund, Germany

Herzzentrum Leipzig GmbH

Leipzig, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

Klinikum der Universität München - Campus Grosshadern

München, Germany

Galway University Hospitals - University Hospital Galway (UHG)

Galway, Ireland

Shaare Zedek Medical Center

Jerusalem, Israel, Israel

Rabin Medical Center- Beilinson Hospital

Petah Tikva, Israel, Israel

Presidio Ospedaliero Gaspare Rodolico

Catania, Italy

Ospedale San Raffaele - Milano

Milan, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

Shonan Kamakura General Hospital

Kanagawa, Kamakura, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Kawasaki Saiwai Hospital

Kawasaki, Kanagawa, Japan

Osaka Keisatsu Hospital

Osaka, Japan

Osaka University Hospital

Osaka, Japan

Catharina Ziekenhuis

Eindhoven, Netherlands, Netherlands

Erasmus MC

Rotterdam, Netherlands, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Hospital Universitari Clínic de Barcelona

Barcelona, Spain, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Skanes Universitetssjukhus

Lund, Sweden

Inselspital - Universitätsspital Bern

Bern, Switzerland

Saint Bartholomew's Hospital

London, United Kingdom