Evolut™ EXPAND TAVR II Pivotal Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

650

Participants

Timeline

Start Date

April 27, 2022

Primary Completion Date

February 28, 2026

Study Completion Date

December 31, 2034

Conditions
Moderate Aortic Valve Stenosis
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).

Trial Locations (97)

1030

Allgemeines Krankenhaus - Universitätskliniken Wien, Vienna

3004

The Alfred Hospital, Melbourne

3010

Inselspital - Universitätsspital Bern, Bern

3015

Erasmus MC, Rotterdam

3100

University Hospital Sankt Poelten, Sankt Pölten

3435

St Antonius Ziekenhuis, Nieuwegein

4000

CHU de Liege- Hopital du Sart Tilman, Liège

6150

Fiona Stanley Hospital, Murdoch

10029

The Mount Sinai Hospital, New York

11030

Northwell Health, Manhasset

17101

UPMC Pinnacle Harrisburg Campus, Harrisburg

18103

Lehigh Valley Hospital, Inc, Allentown

19104

Hospital of the University of Pennsylvania, Philadelphia

20010

MedStar Washington Hospital Center, Washington D.C.

20097

IRCCS Policlinico San Donato, San Donato Milanese

20132

Ospedale San Raffaele - Milano, Milan

21287

The Johns Hopkins Hospital, Baltimore

22185

Skanes Universitetssjukhus, Lund

24014

Carilion Roanoke Memorial Hospital, Roanoke

26506

West Virginia University, Morgantown

27157

Wake Forest University Heatlh Sciences, Winston-Salem

28034

Hospital Universitario Ramón y Cajal, Madrid

28801

Mission Hospital, Asheville

29609

CHRU Brest - Hôpital de la Cavale Blanche, Brest

32204

Saint Vincent's Medical Center Riverside, Jacksonville

32608

University of Florida, Gainesville

32806

Orlando Health, Orlando

33620

Tampa General Hospital, Tampa

33756

Morton Plant Hospital, Clearwater

35233

University of Alabama at Birmingham (UAB) Hospital, Birmingham

37007

Complejo Asistencial Universitario de Salamanca, Salamanca

37403

Erlanger Medical Center, Chattanooga

40202

Jewish Hospital, Louisville

43210

The Ohio State University Wexner Medical Center, Columbus

44137

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

44195

Cleveland Clinic, Cleveland

45429

Kettering Health Main Campus, Kettering

47006

Hospital Clínico Universitario de Valladolid, Valladolid

48236

Ascension Saint John Hospital, Detroit

49100

Rabin Medical Center- Beilinson Hospital, Petah Tikva

49503

Spectrum Health, Grand Rapids

53215

Aurora Saint Lukes Medical Center, Milwaukee

53217

Universitätsklinikum Bonn, Bonn

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

55407

Abbott Northwestern Hospital, Minneapolis

55905

Mayo Clinic, Rochester

57701

Monument Health Rapid City Hospital, Rapid City

63110

SSM Health Saint Louis University Hospital, St Louis

70360

Terrebonne General Medical Center, Houma

73112

Integris Baptist Medical Center, Oklahoma City

75014

Institut Mutualiste Montsouris, Paris

75015

Hôpital Européen Georges Pompidou, Paris

75230

Medical City Dallas, Dallas

76104

Texas Health Harris Methodist Hospital Fort Worth, Fort Worth

77030

Houston Methodist Hospital, Houston

78229

Methodist Hospital San Antonio, San Antonio

79189

Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen

80045

University of Colorado Hospital, Aurora

84111

Intermountain Cardiovascular and Thoracic Surgery, Salt Lake City

85016

Abrazo Arizone Heart Hospital, Phoenix

85260

HonorHealth Scottsdale Shea Medical Center, Scottsdale

91360

Los Robles Hospital & Medical Center, Thousand Oaks

95123

Presidio Ospedaliero Gaspare Rodolico, Catania

97239

Oregon Health & Science University Hospital, Portland

99204

Providence Sacred Heart Medical Center & Children's Hospital, Spokane

9103102

Shaare Zedek Medical Center, Jerusalem

06606-4201

Saint Vincents Medical Center, Bridgeport

06106

Hartford Hospital, Hartford

32308-5054

Tallahassee Memorial Hospital, Tallahassee

02111

Tufts Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01199

Baystate Medical Center, Springfield

48109-1274

University of Michigan Health System - University Hospital, Ann Arbor

03102

Catholic Medical Center, Manchester

08015

Deborah Heart and Lung Center, Browns Mills

076931

Englewood Hospital & Medical Center, Englewood

44106-1716

University Hospitals Cleveland Medical Center, Cleveland

05401-1473

The University of Vermont, Burlington

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H1T1C8

Montreal Heart Hospital, Montreal

G1V 4G5

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

B3H 3A7

Queen Elizabeth II Health Sciences Centre, Halifax

Unknown

CHU de Rennes - Hôpital Pontchaillou, Rennes

Hôpital de la Timone, Marseille

Catharina Ziekenhuis, Eindhoven

63 000

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied, Clermont-Ferrand

04289

Herzzentrum Leipzig GmbH, Leipzig

15, 81377

Klinikum der Universität München - Campus Grosshadern, München

H91 YR71

Galway University Hospitals - University Hospital Galway (UHG), Galway

247-8533

Shonan Kamakura General Hospital, Kanagawa

259-1193

Tokai University Hospital, Isehara

212-0014

Kawasaki Saiwai Hospital, Kawasaki

543-0035

Osaka Keisatsu Hospital, Osaka

565-0871

Osaka University Hospital, Osaka

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

08036

Hospital Universitari Clínic de Barcelona, Barcelona

EC1A 7BE

Saint Bartholomew's Hospital, London

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT05149755 - Evolut™ EXPAND TAVR II Pivotal Trial | Biotech Hunter | Biotech Hunter