Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,426

Participants

Timeline

Start Date

March 21, 2017

Primary Completion Date

February 28, 2021

Study Completion Date

February 28, 2021

Conditions
Atrial Fibrillation
Interventions
DRUG

Edoxaban-based Regimen

15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)

DRUG

VKA-based Regimen

Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).

Trial Locations (230)

1060

Wilhelminenspital, Vienna

1090

Universitätsklinik für Innere Medizin II, Vienna

1130

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel, Vienna

1205

Hopitaux Universitaires de Geneve, Geneva

2060

ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen, Antwerp

2650

UZA - Universtiair Ziekenhuis Antwerpen, Edegem

3010

Bern University Hospital, Bern

3500

Jessa Ziekenhuis- Campus Virga Jessa, Hasselt

3600

ZOL Genk, Campus Sint-Jan, Genk

4031

Universitatsspital Basel, Basel

4289

Herzzentrum Leipzig, Leipzig

4710

Clinic Wels-Grieskirchen GmbH, Grieskirchen

6020

Universitaetsklinik fuer Innere Medizin III, Innsbruck

6900

Cardiocentro Ticino, Lugano

8036

Medizinische Universitaet Graz, Graz

8800

AZ Delta Roeselare, Roeselare

9020

Klinikum Klagenfurt am Worthersee, Klagenfurt

9300

ASZ Aalst - Aalst campus, Aalst

10029

Mt. Sinai Hospital, New York

11030

Northshore Community Hospital, Manhasset

11215

NY Presbyterian - Brooklyn Methodist Hospital, Brooklyn

11548

St. Francis Hospital, East Hills

12100

Ospedale S. Croce e Carle, Cuneo

12200

Charite Universitatsmedizin Berlin, Berlin

13057

St. Joseph's Physicians, East Syracuse

14456

Rochester General Hospital, Geneva

15006

Complexo Hospitalario Universitario de A Coruna, A Coruña

15706

Complexo hospitalario universitario de Santiago de Compostela, A Coruña

16321

Immanuel Klinikum Bernau Herzzentrum Brandenburg, Berlin

17033

Penn State Health, Milton S. Hershey Medical Center, Hershey

17043

Pinnacle Health, Wormleysburg

17403

WellSpan York Hospital, York

18014

Complejo Asistencial de Granada, Granada

18015

St. Luke's University Health Network, Bethlehem

18711

Geisinger Wyoming Valley Medical Center, Wilkes-Barre

18901

Doylestown Health Cardiothoracic Surgery, Doylestown

20010

Medstar Washington Hospital Center, Washington D.C.

20014

Hospital Universitario Donostia, Donostia / San Sebastian

20025

ASST Ovest Milanese - Presidio Ospedallero di Legnana, Legnano

20037

Medical Facility Associates, Washington D.C.

20089

Istituto Clinico Humanitas, Rozzano

20099

Asklepios St. Georg Abteilung fuer Kardiologie, Hamburg

20132

Ospedale San Raffaele, Milan

20138

Centro Cardiologico Monzino IRCCS, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20912

Washington Adventist Hospital, Takoma Park

22042

Inova Heart and Vascular Institute, Falls Church

23795

Segeberger Kliniken, Bad Segeberg

23900

Azienda Socio Sanitaria Territoriale di Lecco, Lecco

24105

Universitaetsklinik Schleswig-Holstein Campus Kiel, Kiel

25123

ASST Spedali Civili di Brescia-UO Cardiologia, Brescia

25404

CAMC Memorial Hospital, Charleston

26133

Klinikum Oldenburg AöR, Oldenburg

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

IRCCS Policlinico San Matteo, Pavia

27401

Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health, Greensboro

27834

East Carolina Heart Institute, Greenville

28003

Hospital La Luz QuironSalud, Madrid

28006

Hospital Universitario La Princesa, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

28046

Hospital Universitario La Paz, Madrid

28277

Gesundheit Nord gGmbH, Bremen

29010

Hospital Universitario Virgen de la Victoria, Málaga

31020

Hospital Virgen de la Arrixaca, Murcia

31300

Clinique Pasteur / GCVI, Toulouse

32117

Cardiology Associate Research, Daytona Beach

32209

UF Health Jacksonville, Jacksonville

32308

Tallahassee Research Institute, Inc., Tallahassee

33011

Hospital Universitario Central de Asturias, Oviedo

33021

Memorial Healthcare Systems, Hollywood

33074

Clinique Saint Augustin, Bordeaux

33166

International Research Partners, LLC., Doral

33604

CHU de Bordeaux Hopital du Haut Leveque, Pessac

33805

Watson Clinic Center for Research, Lakeland

34295

CHU Arnaud de Villeneuve, Montpellier

34960

Clinique du Millenaire Service de Cardiologie Interventionelle, Montpellier

35121

Azienda Ospedaliera di Padova, Padua

35233

University of Alabama at Birmingham, Birmingham

36043

Klinikum Fulda gAG, Fulda

36312

Hospital Universitario Alvaro Cunqueiro, Vigo

37126

Azienda Ospedaliera Integrata di Verona, Verona

37203

SCRI - Centennial Medical Center, Nashville

39008

Valdecilla Hospital, Santander

39216

Jackson Heart Clinic, Jackson

40138

Policlinico Sant'Orsola-Malpighi, Bologna

40225

Universitätsklinikum Düsseldorf, Düsseldorf

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

42117

Helios Herzzentrum Wuppertal, Wuppertal

42123

IRCCS-ASMN Reggio Emilia, Reggio Emilia

43615

Promedica Toledo Hospital, Toledo

44137

Klinikum der Stadt Ludwigshafen, Dortmund

St. Johannes - Hospital, Dortmund

45138

Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie, Essen

46010

Hospital Clinico de Valencia, Valencia

47003

Hospital Clinico Universitario de Valladolid, Valladolid

48197

Michigan Heart, St. Joseph Mercy Health System, Ypsilanti

48670

MidMichigan Medical Center Midland, Midland

48912

Sparrow Clinical Research Institute, Lansing

52242

University of Iowa Hospitals and Clinics, Iowa City

53100

UOC Emodinamica III, Siena

53215

Aurora St. Luke's Medical Center, Milwaukee

54100

Fondazione Toscana Gabriele Monasterio, Massa

54292

Krankenhaus der Barmherzigen, Trier

55104

HealthEast Medical Research Institute, Saint Paul

55131

Universitatsmedizin Mainz, Zentrum fur Kardiologie, Mainz

55805

Essentia Health, Duluth

55905

Mayo Clinic Rochester, Rochester

56124

Azienda Ospedaliero-Universitaria Pisana, Pisa

57701

Black Hills Cardiovascular Research, Rapid City

59000

Institut Coeur Poumon - CHRU de Lille, Lille

60030

Ospedali Riuniti Torrette Di Ancona, Ancona

60612

Rush University Medical Center, Chicago

61231

Kerckhoff-Klinik, Bad Nauheim

61801

Carle Foundation Hospital, Urbana

63119

Clinical Investigators LLC, St Louis

67091

Nouvel Hopital Civil, Strasbourg

69120

Heidelberg University Hospital, Heidelberg

72076

Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III, Tübingen

72211

Arkansas Site Management Services, Little Rock

73100

Citta di Lecce Hospital, Lecce

73120

Oklahoma Heart Hospital Research Foundation, Oklahoma City

75014

Institut Mutualiste Montsouris, Paris

75024

Legacy Heart Center, Plano

75877

Hopital Bichat, Paris

76000

CHU de Rouen, Rouen

Clinique Saint-Hilaire, Rouen

77030

St. Vincent Heart Center, Indianapolis

Houston Methodist Research Institute, Houston

University of Texas Health Science Center Houston, Houston

77933

MediClin Herzzentrum Lahr/Baden, Lahr

78745

Seton Heart Institute, Austin

80122

Clinica Mediterranea, Napoli

80131

A.A Dei Colli Monaldi UOC Cardiologia Interventistica, Napoli

80636

Deutsches Herzzentrum Munchen, München

81379

Universitatsklinikum Essen, Klinik fur Kardiologie, München

81675

Klinikum rechts der Isar der Technischen Universitat Munchen, München

84133

AOU S.Giovanni Di Dio e Ruggi D'Aragona, Salerno

85724

University of Arizona Sarver Heart Center, Tucson

87102

New Mexico Heart Institute, Albuquerque

88100

Magna Graecia University, Catanzaro

89081

Universitatsklinikum Ulm, Ulm

89502

Renown Regional Medical Center, Reno

90048

Cedar-Sinai Heart Institute, Los Angeles

90095

UCLA Cardiovascular Center, Los Angeles

92354

Loma Linda University Medical Center, Loma Linda

93042

Uniklinikum Regensburg, Med II, Regensburg

94000

Hopital Henri Mondor, Créteil

94143

University of California - San Francisco, San Francisco

95030

Centro Cuore Morgagni, Pedara

95123

AOU Policlinico Vittorio Emanuele, Catania

97080

Universitatsklinikum Wurzburg, Würzburg

97225

Providence Heart and Vascular Institute, Portland

97504

Southern Oregon Cardiology, Medford

97616

Herz und Gefaess Klinik, Bad Neustadt an der Saale

98101

Virginia Mason Medical Center, Seattle

99208

Providence Sacred Heart Medical Research Center, Spokane

93105-4365

Santa Barbara Cottage Hospital, Santa Barbara

04074-7133

Maine Medical Center, Scarborough

01199

Baystate Health, Springfield

01655

University of Massachusetts Memorial Medical Center, Worcester

07601

Hackensack University Medical Center, Hackensack

07652

The Valley Hospital, Paramus

11794-8167

Stony Brook University Medical Center, Stony Brook

B-1070

Hospital Erasme, Brussels

B-4000

CHU de Liege, Liège

T6G 2R7

University of Alberta Hospital, Edmonton

K7L 2V7

Kingston Health Sciences Centre, Kingston

N6A 5W9

London Health Sciences Centre, London

L3Y 3S9

Newmarket Cardiac Surgery Research Incorporated, Newmarket

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 2C4

University Health Network, Toronto

H1T 1C8

Montreal Heart Institute, Montreal

L8L 2X2

Hamilton General Hospital, Hamilton

G1V 4G5

Universitè Laval, Québec

E2L4L2

Horizon Health Network, Saint John

Unknown

CHU d'Angers, Angers

IRCCS Policlinico San Donato, San Donato Milanese

Seoul National University Hospital, Seoul

Yonsei University Severance Hospital, Seoul

Asan Medical Center, Seoul

01307

Heart Center Dresden, University Clinic Technical University Dresden, Dresden

06120

Universitatsklinikum Halle (Saale), Halle

00152

AO San Camillo Forlanini, Rome

00161

Azienda Ospedaliero-Universitaria Policlinico Umberto I, Rome

00187

AOU Careggi, Interventistica Cardiologica Strutturale, Rome

00189

Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica, Rome

441-8530

Nagoya Heart Center, Toyohashi

Toyohashi Heart Center, Aichi

802-8555

Kokura Memorial Hospital, Kitakyushu

503-0864

Ogaki Municipal Hospital, Ōgaki

065-0033

Sapporo Higashi Tokushukai Hospital, Sapporo

305-8558

Tsukuba Medical Center Hospital, Amakubo

173-0003

Teikyo University Hospital, Tokyo

020-8505

Iwate Medical University Hospital, Morioka

259-1193

Tokai University Hospital, Isehara

216-0015

St. Marianna University School of Medicine Hospital, Kawasaki

230-8765

Saiseikai Yokohamashi Tobu Hospital, Yokohama

980-0873

Sendai Kousei Hospital, Sendai

545-8586

Osaka City University Hospital, Abeno Ward

596-0042

Kishiwada Tokushukai Hospital, Kishiwada

160-0016

Keio University Hospital, Shinjuku

270-2232

New Tokyo Hospital, Chiba

247-0072

Shonan Kamakura General Hospital, Kanagawa

930-0194

Toyama University Hospital, Toyama

1105 AZ

Academic Medical Center, Amsterdam

9713 GZ

University Medical Center Groningen, Groningen

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

3015 CN

Erasmus Medical Center, Rotterdam

2504 LN

HagaZiekenhuis, The Hague

15-276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

80-952

University Clinical Centre in Gdańsk, Gdansk

61-848

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan

06591

Seoul St. Mary's Hospital, Seoul

02841

Korean University Anam Hospital, Seoul

08916

Hospital Universitari Germans Trias I Pujol, Badalona

03540

Hospital General Universitario de Alicante, Alicante

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinico y Provincial de Barcelona, Barcelona

BN2 5BE

BSUH, Cardiac Research Unit, Brighton

CB23 3RE

Papworth Hospital NHS Foundation Trust, Cambridge

EH16 4SA

Royal Edinburgh Infirmary, Edinburgh

SE1 7EH

Guys St Thomas Hospital, London

NG5 1PB

Trent Cardiac Centre, Nottingham

OX3 9DU

Oxford University Hospitals, John Radcliffe Hospital, Oxford

S5 7AU

Northern General Hospital, Sheffield

CF14 4XW

University Hospital of Wales, Heath Park, Cardiff

LE3 9QP

University Hospitals of Leicester NHS Trust, Leicester

PL6 8DH

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Chiltern International Inc.

INDUSTRY

lead

Daiichi Sankyo

INDUSTRY