Clinical trial NCT02943785: Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
Official title: Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation (TAVI) - in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Transcatheter Aortic Valve Implantation -- TAVI
Anticoagulation
Atrial Fibrillation
ENVISAGE-TAVI-AF
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Chiltern International Inc.
First posted: 2016-10-25
Enrollment: 1426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation.

Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters.

Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

Detailed description: Use of Edoxaban in patients with atrial fibrillation (AF) and indication to chronic oral anticoagulation (OAC) after transcatheter aortic valve implantation (TAVI)

Objective:

* To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and major bleeding (International Society on Thrombosis and Haemostasis \[ISTH\] definition).
* To assess the effect of Edoxaban versus VKA on major bleeding (ISTH definition).

Eligibility criteria: Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to comply with any restrictions related food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Primary outcomes:
measure: Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA
timeFrame: Baseline through study completion, up to 36 months post-dose
Secondary outcomes:
measure: Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Myocardial Infarctions (MI) in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
measure: Number of Participants Who Experienced Valve Thrombosis in Participants Taking Edoxaban vs VKA (Adjudicated Data)
timeFrame: Baseline through study completion, up to 36 months post-dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona Sarver Heart Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Site Management Services
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedar-Sinai Heart Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Cardiovascular Center
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Medical Facility Associates
state: District of Columbia
city: Daytona Beach
country: United States
facility: Cardiology Associate Research
state: Florida
city: Doral
country: United States
facility: International Research Partners, LLC.
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare Systems
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center for Research
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute, Inc.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Heart Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Midland
country: United States
facility: MidMichigan Medical Center Midland
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart, St. Joseph Mercy Health System
state: Michigan
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast Medical Research Institute
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Clinical Investigators LLC
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute
state: New Mexico
city: Brooklyn
country: United States
facility: NY Presbyterian - Brooklyn Methodist Hospital
state: New York
city: East Hills
country: United States
facility: St. Francis Hospital
state: New York
city: East Syracuse
country: United States
facility: St. Joseph's Physicians
state: New York
city: Geneva
country: United States
facility: Rochester General Hospital
state: New York
city: Manhasset
country: United States
facility: Northshore Community Hospital
state: New York
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Heart Institute
state: North Carolina
city: Toledo
country: United States
facility: Promedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Medford
country: United States
facility: Southern Oregon Cardiology
state: Oregon
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Doylestown
country: United States
facility: Doylestown Health Cardiothoracic Surgery
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Health, Milton S. Hershey Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: York
country: United States
facility: WellSpan York Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research
state: South Dakota
city: Nashville
country: United States
facility: SCRI - Centennial Medical Center
state: Tennessee
city: Austin
country: United States
facility: Seton Heart Institute
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center Houston
state: Texas
city: Plano
country: United States
facility: Legacy Heart Center
state: Texas
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Research Center
state: Washington
city: Charleston
country: United States
facility: CAMC Memorial Hospital
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Grieskirchen
country: Austria
facility: Clinic Wels-Grieskirchen GmbH
city: Innsbruck
country: Austria
facility: Universitaetsklinik fuer Innere Medizin III
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Worthersee
city: Vienna
country: Austria
facility: Universitätsklinik für Innere Medizin II
city: Vienna
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
city: Wien
country: Austria
facility: Wilhelminenspital
city: Aalst
country: Belgium
facility: ASZ Aalst - Aalst campus
city: Antwerpen
country: Belgium
facility: ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Edegem
country: Belgium
facility: UZA - Universtiair Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: ZOL Genk, Campus Sint-Jan
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis- Campus Virga Jessa
city: Liège
country: Belgium
facility: CHU de Liege
city: Roeselare
country: Belgium
facility: AZ Delta Roeselare
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Newmarket
country: Canada
facility: Newmarket Cardiac Surgery Research Incorporated
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Hamilton
country: Canada
facility: Hamilton General Hospital
city: Québec
country: Canada
facility: Universitè Laval
city: Saint John
country: Canada
facility: Horizon Health Network
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Lille
country: France
facility: Institut Coeur Poumon - CHRU de Lille
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Montpellier
country: France
facility: Clinique du Millenaire Service de Cardiologie Interventionelle
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hopital Bichat
city: Pessac
country: France
facility: CHU de Bordeaux Hopital du Haut Leveque
city: Rouen
country: France
facility: CHU de Rouen
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Toulouse
country: France
facility: Clinique Pasteur / GCVI
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz und Gefaess Klinik
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg
city: Bremen
country: Germany
facility: Gesundheit Nord gGmbH
city: Dortmund
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Dortmund
country: Germany
facility: St. Johannes - Hospital
city: Dresden
country: Germany
facility: Heart Center Dresden, University Clinic Technical University Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Halle
country: Germany
facility: Universitatsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Asklepios St. Georg Abteilung fuer Kardiologie
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
city: Kiel
country: Germany
facility: Universitaetsklinik Schleswig-Holstein Campus Kiel
city: Lahr
country: Germany
facility: MediClin Herzzentrum Lahr/Baden
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Mainz
country: Germany
facility: Universitatsmedizin Mainz, Zentrum fur Kardiologie
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitat Munchen
city: München
country: Germany
facility: Deutsches Herzzentrum Munchen
city: München
country: Germany
facility: Universitatsklinikum Essen, Klinik fur Kardiologie
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg AöR
city: Regensburg
country: Germany
facility: Uniklinikum Regensburg, Med II
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Wuppertal
country: Germany
facility: Helios Herzzentrum Wuppertal
city: Würzburg
country: Germany
facility: Universitatsklinikum Wurzburg
city: Ancona
country: Italy
facility: Ospedali Riuniti Torrette Di Ancona
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia-UO Cardiologia
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele
city: Catanzaro
country: Italy
facility: Magna Graecia University
city: Cuneo
country: Italy
facility: Ospedale S. Croce e Carle
city: Lecce
country: Italy
facility: Citta di Lecce Hospital
city: Lecco
country: Italy
facility: Azienda Socio Sanitaria Territoriale di Lecco
city: Legnano
country: Italy
facility: ASST Ovest Milanese - Presidio Ospedallero di Legnana
city: Massa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Centro Cardiologico Monzino IRCCS
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Napoli
country: Italy
facility: A.A Dei Colli Monaldi UOC Cardiologia Interventistica
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Pedara
country: Italy
facility: Centro Cuore Morgagni
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Reggio Emilia
country: Italy
facility: IRCCS-ASMN Reggio Emilia
city: Rome
country: Italy
facility: AO San Camillo Forlanini
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I
city: Rome
country: Italy
facility: AOU Careggi, Interventistica Cardiologica Strutturale
city: Rome
country: Italy
facility: Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: AOU S.Giovanni Di Dio e Ruggi D'Aragona
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
city: Siena
country: Italy
facility: UOC Emodinamica III
city: Verona
country: Italy
facility: Azienda Ospedaliera Integrata di Verona
city: Toyohashi
country: Japan
facility: Nagoya Heart Center
state: Aichi
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Ōgaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Amakubo
country: Japan
facility: Tsukuba Medical Center Hospital
state: Ibaraki
city: Tokyo
country: Japan
facility: Teikyo University Hospital
state: Itabashi
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate Prefecture
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Abeno Ward
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Shinjuku City
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Aichi
country: Japan
facility: Toyohashi Heart Center
city: Chiba
country: Japan
facility: New Tokyo Hospital
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-gu
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
state: Seodaemun-gu
city: Seoul
country: Korea, Republic of
facility: Korean University Anam Hospital
state: Seongbuk-gu
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Gdańsk
country: Poland
facility: University Clinical Centre in Gdańsk
city: Poznań
country: Poland
facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Barcelona
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: A Coruña
country: Spain
facility: Complexo hospitalario universitario de Santiago de Compostela
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinico y Provincial de Barcelona
city: Grenada
country: Spain
facility: Complejo Asistencial de Granada
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario de A Coruna
city: Madrid
country: Spain
facility: Hospital La Luz QuironSalud
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Santander
country: Spain
facility: Valdecilla Hospital
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Universitario Alvaro Cunqueiro
city: Basel
country: Switzerland
facility: Universitatsspital Basel
city: Bern
country: Switzerland
facility: Bern University Hospital
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Brighton
country: United Kingdom
facility: BSUH, Cardiac Research Unit
state: England
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: England
city: Edinburgh
country: United Kingdom
facility: Royal Edinburgh Infirmary
state: England
city: London
country: United Kingdom
facility: Guys St Thomas Hospital
state: England
city: Nottingham
country: United Kingdom
facility: Trent Cardiac Centre
state: England
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals, John Radcliffe Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
state: England
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Heath Park
state: Wales
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Van Mieghem NM, Unverdorben M, Hengstenberg C, Mollmann H, Mehran R, Lopez-Otero D, Nombela-Franco L, Moreno R, Nordbeck P, Thiele H, Lang I, Zamorano JL, Shawl F, Yamamoto M, Watanabe Y, Hayashida K, Hambrecht R, Meincke F, Vranckx P, Jin J, Boersma E, Rodes-Cabau J, Ohlmann P, Capranzano P, Kim HS, Pilgrim T, Anderson R, Baber U, Duggal A, Laeis P, Lanz H, Chen C, Valgimigli M, Veltkamp R, Saito S, Dangas GD; ENVISAGE-TAVI AF Investigators. Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR. N Engl J Med. 2021 Dec 2;385(23):2150-2160. doi: 10.1056/NEJMoa2111016. Epub 2021 Aug 28.
citation: Giacoppo D. Anticoagulation After Transcatheter Aortic Valve Replacement: Evolving Answers and Still Unaddressed Questions. JACC Cardiovasc Interv. 2021 Aug 9;14(15):1714-1716. doi: 10.1016/j.jcin.2021.06.004. Epub 2021 Jul 14. No abstract available.
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