SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,103

Participants

Timeline

Start Date

April 2, 2021

Primary Completion Date

November 10, 2023

Study Completion Date

December 31, 2027

Conditions
Symptomatic Aortic StenosisAortic Valve StenosisAortic Valve Replacement
Interventions
DEVICE

Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems

TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)

DEVICE

Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems

TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System

Trial Locations (92)

10016

NYU Langone Medical Center, New York

10029

The Icahn School of Medicine at Mount Sinai, New York

10065

Weill Cornell Medical Center, New York

14203

Buffalo General Medical Center, Buffalo

15212

Allegheny General Hospital, Pittsburgh

15213

UPMC Presbyterian, Pittsburgh

17110

UPMC Pinnacle Harrisburg, Harrisburg

17403

York Hospital, York

19096

Lankenau Medical Center, Wynnewood

19104

Hospital of the University of Pennsylvania, Philadelphia

Penn Presbyterian Medical Center, Philadelphia

20010

WHC Washington MedStar, Washington D.C.

22042

Inova Fairfax Hospital, Falls Church

22903

University of Virginia, Charlottesville

23507

Sentara Norfolk General Hospital, Norfolk

26506

J.W. Ruby Memorial Hospital/West Virginia University, Morgantown

27599

UNC Memorial Hospital, Chapel Hill

28801

Mission Hospital, Asheville

30060

Wellstar Kennestone Hospital, Marietta

30308

Emory Structural Heart Clinic and Emory University Midtown, Atlanta

30309

Piedmont Atlanta Hospital, Atlanta

32608

University of Florida, Gainesville

33140

Mount Sinai Medical Center, Miami Beach

33756

Morton Plant Hospital, Clearwater

33908

HealthPark Medical Center, Fort Myers

37203

TriStar Centennial Medical Center, Nashville

37205

St. Thomas West Hospital, Nashville

44106

University Hospitals Cleveland Medical Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

45220

TriHealth / Bethesda North Hospital, Cincinnati

46290

Saint Vincent Heart Center of Indiana, Carmel

48109

University of Michigan, Ann Arbor

48236

Ascension St. John Hospital, Detroit

49503

Spectrum Health, Grand Rapids

52242

University of Iowa Hospitals and Clinics, Iowa City

55905

Mayo Clinic, Rochester

56303

St. Cloud Hospital, Saint Cloud

60201

NorthShore Health Systems, Evanston

60453

Advocate Christ Medical Center, Oak Lawn

63131

Missouri Baptist Medical Center, St Louis

66160

University of Kansas Medical Center, Kansas City

67226

AscensionVia Christi St. Francis Hospital, Wichita

74104

Hillcrest Medical Center, Tulsa

75093

The Heart Hospital Baylor Plano, Plano

75226

Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas

76231

Texas Health Presbyterian Hospital/Dallas, Dallas

77030

Baylor Saint Luke's Hospital, Houston

Houston Methodist Hospital, Houston

The University of Texas Health Science Center at Houston, Houston

University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure, Houston

78705

Seton Heart Institute, Austin

80045

University of Colorado, Aurora

84107

Intermountain Medical Center, Murray

84770

Saint George Regional Hospital, St. George

90048

Cedars Sinai Medical Center, Los Angeles

91360

Los Robles Hospital and Medical Center, Thousand Oaks

92037

Scripps Memorial Hospital, La Jolla

94109

Sutter Health, San Francisco

06510

Yale New Haven Hospital, New Haven

02111

Tufts Medical Center, Boston

07960

Morristown Medical Center, Morristown

V6Z 1Y6

Providence Health-St. Paul's Hospital, Vancouver

Unknown

Victoria Heart Institute Foundation/Royal Jubilee Hospital, Victoria

St. Michaels Hospital/Unity Health Toronto, Toronto

Rigshospitalet, Copenhagen

Helsinki University Hospital, Helsinki

Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand

CHU Bordeaux, Pessac

Clinique Pasteur, Toulouse

Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum, Bad Oeynhausen

Deutsches Herzzentrum Berlin, Berlin

Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund, Dortmund

Universitätsklinikum Düsseldorf, Düsseldorf

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Kiel

Helios Health Institute GmbH, Leipzig

Universitätsklinikum Schleswig-Holstein - Campus Lübeck, Lübeck

Deutsches Herzzentrum Munchen, München

Sheba Medical Center, Ramat Gan

Tel Aviv Sourasky Medical Center, Tel Aviv

Policlinico Sant' Orsala - Malpighi, Bologna

Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello, Pisa

AOU Integrata Verona, Verona

Catharina Ziekenhuis, Eindhoven

Maastricht Universitair Medisch Centrum (MUMC), Maastricht

HagaZiekenhuis - Locatie Leyweg, The Hague

Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz, Carnaxide

Hospital Vall d'Hebron, Barcelona

Inselspital - Universitätsspital Bern, Bern

Royal Infirmary of Edinburgh, Edinburgh

The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary, Leeds

M5G 2C4

Toronto General Hospital, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

Sponsors
All Listed Sponsors
lead

Medtronic Cardiovascular

INDUSTRY

NCT04722250 - SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial | Biotech Hunter | Biotech Hunter