Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Transcatheter Aortic Valve Implantation -- TAVI, Anticoagulation, Atrial Fibrillation, ENVISAGE-TAVI-AF
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:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Sites / Locations
- University of Alabama at Birmingham
- University of Arizona Sarver Heart Center
- Arkansas Site Management Services
- Loma Linda University Medical Center
- Cedar-Sinai Heart Institute
- UCLA Cardiovascular Center
- University of California - San Francisco
- Santa Barbara Cottage Hospital
- Medstar Washington Hospital Center
- Medical Facility Associates
- Cardiology Associate Research
- International Research Partners, LLC.
- Memorial Healthcare Systems
- UF Health Jacksonville
- Watson Clinic Center for Research
- Tallahassee Research Institute, Inc.
- Rush University Medical Center
- Carle Foundation Hospital
- St. Vincent Heart Center
- University of Iowa Hospitals and Clinics
- Maine Medical Center
- Washington Adventist Hospital
- Baystate Health
- University of Massachusetts Memorial Medical Center
- Sparrow Clinical Research Institute
- MidMichigan Medical Center Midland
- Michigan Heart, St. Joseph Mercy Health System
- Essentia Health
- Mayo Clinic Rochester
- HealthEast Medical Research Institute
- Jackson Heart Clinic
- Clinical Investigators LLC
- Renown Regional Medical Center
- Hackensack University Medical Center
- The Valley Hospital
- New Mexico Heart Institute
- NY Presbyterian - Brooklyn Methodist Hospital
- St. Francis Hospital
- St. Joseph's Physicians
- Rochester General Hospital
- Northshore Community Hospital
- Mt. Sinai Hospital
- Stony Brook University Medical Center
- Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
- East Carolina Heart Institute
- Promedica Toledo Hospital
- Oklahoma Heart Hospital Research Foundation
- Southern Oregon Cardiology
- Providence Heart and Vascular Institute
- St. Luke's University Health Network
- Doylestown Health Cardiothoracic Surgery
- Penn State Health, Milton S. Hershey Medical Center
- Geisinger Wyoming Valley Medical Center
- Pinnacle Health
- WellSpan York Hospital
- Black Hills Cardiovascular Research
- SCRI - Centennial Medical Center
- Seton Heart Institute
- Houston Methodist Research Institute
- University of Texas Health Science Center Houston
- Legacy Heart Center
- Inova Heart and Vascular Institute
- Virginia Mason Medical Center
- Providence Sacred Heart Medical Research Center
- CAMC Memorial Hospital
- Aurora St. Luke's Medical Center
- Medizinische Universitaet Graz
- Clinic Wels-Grieskirchen GmbH
- Universitaetsklinik fuer Innere Medizin III
- Klinikum Klagenfurt am Worthersee
- Universitätsklinik für Innere Medizin II
- Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
- Wilhelminenspital
- ASZ Aalst - Aalst campus
- ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen
- Hospital Erasme
- UZA - Universtiair Ziekenhuis Antwerpen
- ZOL Genk, Campus Sint-Jan
- Jessa Ziekenhuis- Campus Virga Jessa
- CHU de Liege
- AZ Delta Roeselare
- University of Alberta Hospital
- Kingston Health Sciences Centre
- London Health Sciences Centre
- Newmarket Cardiac Surgery Research Incorporated
- Sunnybrook Health Sciences Centre
- University Health Network
- Montreal Heart Institute
- Hamilton General Hospital
- Universitè Laval
- Horizon Health Network
- CHU d'Angers
- Clinique Saint Augustin
- Hopital Henri Mondor
- Institut Coeur Poumon - CHRU de Lille
- CHU Arnaud de Villeneuve
- Clinique du Millenaire Service de Cardiologie Interventionelle
- Institut Mutualiste Montsouris
- Hopital Bichat
- CHU de Bordeaux Hopital du Haut Leveque
- CHU de Rouen
- Clinique Saint-Hilaire
- Nouvel Hopital Civil
- Clinique Pasteur / GCVI
- Kerckhoff-Klinik
- Herz und Gefaess Klinik
- Segeberger Kliniken
- Charite Universitatsmedizin Berlin
- Immanuel Klinikum Bernau Herzzentrum Brandenburg
- Gesundheit Nord gGmbH
- Klinikum der Stadt Ludwigshafen
- St. Johannes - Hospital
- Heart Center Dresden, University Clinic Technical University Dresden
- Universitätsklinikum Düsseldorf
- Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie
- Klinikum Fulda gAG
- Universitatsklinikum Halle (Saale)
- Asklepios St. Georg Abteilung fuer Kardiologie
- Heidelberg University Hospital
- Universitaetsklinik Schleswig-Holstein Campus Kiel
- MediClin Herzzentrum Lahr/Baden
- Herzzentrum Leipzig
- Universitatsmedizin Mainz, Zentrum fur Kardiologie
- Klinikum rechts der Isar der Technischen Universitat Munchen
- Deutsches Herzzentrum Munchen
- Universitatsklinikum Essen, Klinik fur Kardiologie
- Klinikum Oldenburg AöR
- Uniklinikum Regensburg, Med II
- Krankenhaus der Barmherzigen
- Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III
- Universitatsklinikum Ulm
- Helios Herzzentrum Wuppertal
- Universitatsklinikum Wurzburg
- Ospedali Riuniti Torrette Di Ancona
- Policlinico Sant'Orsola-Malpighi
- ASST Spedali Civili di Brescia-UO Cardiologia
- AOU Policlinico Vittorio Emanuele
- Magna Graecia University
- Ospedale S. Croce e Carle
- Citta di Lecce Hospital
- Azienda Socio Sanitaria Territoriale di Lecco
- ASST Ovest Milanese - Presidio Ospedallero di Legnana
- Fondazione Toscana Gabriele Monasterio
- Ospedale San Raffaele
- Centro Cardiologico Monzino IRCCS
- ASST Grande Ospedale Metropolitano Niguarda
- Clinica Mediterranea
- A.A Dei Colli Monaldi UOC Cardiologia Interventistica
- Azienda Ospedaliera di Padova
- Fondazione IRCCS Policlinico San Matteo
- IRCCS Policlinico San Matteo
- Centro Cuore Morgagni
- Azienda Ospedaliero-Universitaria Pisana
- IRCCS-ASMN Reggio Emilia
- AO San Camillo Forlanini
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- AOU Careggi, Interventistica Cardiologica Strutturale
- Ospedale Sant'Andrea - U.O.S. Emodinamica Cardiologia Interventistica
- Istituto Clinico Humanitas
- AOU S.Giovanni Di Dio e Ruggi D'Aragona
- IRCCS Policlinico San Donato
- UOC Emodinamica III
- Azienda Ospedaliera Integrata di Verona
- Nagoya Heart Center
- Kokura Memorial Hospital
- Ogaki Municipal Hospital
- Sapporo Higashi Tokushukai Hospital
- Tsukuba Medical Center Hospital
- Teikyo University Hospital
- Iwate Medical University Hospital
- Tokai University Hospital
- St. Marianna University School of Medicine Hospital
- Saiseikai Yokohamashi Tobu Hospital
- Sendai Kousei Hospital
- Osaka City University Hospital
- Kishiwada Tokushukai Hospital
- Keio University Hospital
- Toyohashi Heart Center
- New Tokyo Hospital
- Shonan Kamakura General Hospital
- Toyama University Hospital
- Seoul National University Hospital
- Seoul St. Mary's Hospital
- Yonsei University Severance Hospital
- Korean University Anam Hospital
- Asan Medical Center
- Academic Medical Center
- HagaZiekenhuis
- University Medical Center Groningen
- Medisch Centrum Leeuwarden
- Erasmus Medical Center
- Uniwersytecki Szpital Kliniczny w Bialymstoku
- University Clinical Centre in Gdańsk
- Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
- Hospital Universitario Virgen Macarena
- Hospital Universitario Central de Asturias
- Hospital Universitari Germans Trias I Pujol
- Hospital Universitario Donostia
- Complexo hospitalario universitario de Santiago de Compostela
- Hospital General Universitario de Alicante
- Hospital Universitario Vall d'Hebron
- Hospital Clinico y Provincial de Barcelona
- Complejo Asistencial de Granada
- Complexo Hospitalario Universitario de A Coruna
- Hospital La Luz QuironSalud
- Hospital Universitario La Princesa
- Hospital Universitario Ramón y Cajal
- Hospital Clinico San Carlos
- Hospital Universitario La Paz
- Hospital Virgen de la Arrixaca
- Hospital Universitario Virgen de la Victoria
- Valdecilla Hospital
- Hospital Universitario Virgen del Rocio
- Hospital Clinico de Valencia
- Hospital Clinico Universitario de Valladolid
- Hospital Universitario Alvaro Cunqueiro
- Universitatsspital Basel
- Bern University Hospital
- Hopitaux Universitaires de Geneve
- Cardiocentro Ticino
- BSUH, Cardiac Research Unit
- Papworth Hospital NHS Foundation Trust
- Royal Edinburgh Infirmary
- Guys St Thomas Hospital
- Trent Cardiac Centre
- Oxford University Hospitals, John Radcliffe Hospital
- Northern General Hospital
- University Hospital of Wales, Heath Park
- University Hospitals of Leicester NHS Trust
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Edoxaban-based Regimen
VKA-based Regimen
Edoxaban-based regimen 60 mg and 30 mg film coated tablet for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing must follow the locally approved label.
VKA-based regimen oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator will monitor the patient and adjust the VKA dose to maintain the dose within target.