Last updated on August 2018

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


Brief description of study

When the upper chambers of a person's heart receive irregular electrical signals it causes abnormal rhythm in the heart beat. This is called atrial fibrillation.

Atrial fibrillation increases the chance of having a heart attack or stroke. Some patients also get new heart valves using a catheter.

Often doctors give patients a medicine called a vitamin K antagonist (VKA), because it is considered the standard care. This study will see how edoxaban compares to VKA in patients who got a new heart valve by using a catheter.

The study will compare the two drugs for up to three years after heart valve replacement, looking at the drug's overall side effects (called adverse events) and major bleeding.

Detailed Study 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).

Clinical Study Identifier: NCT02943785

Contact Investigators or Research Sites near you

Start Over

Principal Investigator

Arkansas Site Management Services
Little Rock, AR United States
  Connect »

Principal Investigator

Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, NC United States
  Connect »

Principal Investigator

University of Alabama at Birmingham
Birmingham, AL United States
  Connect »

Principal Investigator

University of Arizona Sarver Heart Center
Tucson, AZ United States
  Connect »

Principal Investigator

University of California - San Francisco
San Francisco, CA United States
  Connect »

Principal Investigator

Medstar Washington Hospital Center
Washington, WA United States
  Connect »

Principal Investigator

Medical Facility Associates
Washington, WA United States
  Connect »

Principal Investigator

Cardiology Associate Research
Daytona Beach, FL United States
  Connect »

Principal Investigator

International Research Partners, LLC.
Doral, FL United States
  Connect »

Principal Investigator

Watson Clinic Center for Research
Lakeland, FL United States
  Connect »

Principal Investigator

Tallahassee Research Institute, Inc.
Tallahassee, FL United States
  Connect »

Principal Investigator

Carle Foundation Hospital
Urbana, IL United States
  Connect »

Principal Investigator

St. Vincent Heart Center
Indianapolis, IN United States
  Connect »

Principal Investigator

University of Iowa Hospitals and Clinics
Iowa City, IA United States
  Connect »

Principal Investigator

Washington Adventist Hospital
Takoma Park, MD United States
  Connect »

Principal Investigator

Sparrow Clinical Research Institute
Lansing, MI United States
  Connect »

Principal Investigator

MidMichigan Medical Center Midland
Midland, MI United States
  Connect »

Principal Investigator

Michigan Heart, St. Joseph Mercy Health System
Ypsilanti, MI United States
  Connect »

Principal Investigator

Essentia Health
Duluth, MN United States
  Connect »

Principal Investigator

Mayo Clinic Rochester
Rochester, MN United States
  Connect »

Principal Investigator

Jackson Heart Clinic
Jackson, MS United States
  Connect »

Principal Investigator

Hackensack University Medical Center
Hackensack, NJ United States
  Connect »

Principal Investigator

The Valley Hospital
Paramus, NJ United States
  Connect »

Principal Investigator

New Mexico Heart Institute
Albuquerque, NM United States
  Connect »

Principal Investigator

NY Presbyterian - Brooklyn Methodist Hospital
Brooklyn, NY United States
  Connect »

Principal Investigator

St. Joseph's Physicians
East Syracuse, NY United States
  Connect »

Principal Investigator

Rochester General Hospital
Geneva, NY United States
  Connect »

Principal Investigator

Mt. Sinai Hospital
New York, NY United States
  Connect »

Principal Investigator

Oklahoma Heart Hospital Research Foundation
Oklahoma City, OK United States
  Connect »

Principal Investigator

Providence Heart and Vascular Institute
Portland, OR United States
  Connect »

Principal Investigator

Doylestown Health Cardiothoracic Surgery
Doylestown, PA United States
  Connect »

Principal Investigator

Penn State Health, Milton S. Hershey Medical Center
Hershey, PA United States
  Connect »

Principal Investigator

Pinnacle Health
Wormleysburg, PA United States
  Connect »

Principal Investigator

WellSpan York Hospital
York, PA United States
  Connect »

Principal Investigator

Seton Heart Institute
Austin, TX United States
  Connect »

Principal Investigator

Houston Methodist Research Institute
Houston, TX United States
  Connect »

Principal Investigator

University of Texas Health Science Center Houston
Houston, TX United States
  Connect »

Principal Investigator

CAMC Memorial Hospital
Charleston, WV United States
  Connect »

Principal Investigator

Medizinische Universitaet Graz
Graz, Austria
  Connect »

Principal Investigator

Universitaetsklinik fuer Innere Medizin III
Innsbruck, Austria
  Connect »

Principal Investigator

Universit tsklinik f r Innere Medizin II
Vienna, Austria
  Connect »

Principal Investigator

ZNA - Stuivenberg Ziekenhuis Netwerk Antwerpen
Antwerpen, Belgium
  Connect »

Principal Investigator

UZA - Universtiair Ziekenhuis Antwerpen
Edegem, Belgium
  Connect »

Principal Investigator

ZOL Genk, Campus Sint-Jan
Genk, Belgium
  Connect »

Principal Investigator

Jessa Ziekenhuis- Campus Virga Jessa
Hasselt, Belgium
  Connect »

Principal Investigator

London Health Sciences Centre
London, ON Canada
  Connect »

Principal Investigator

Hamilton General Hospital
Hamilton, Canada
  Connect »

Principal Investigator

Horizon Health Network
Saint John, Canada
  Connect »

Principal Investigator

CHU d'Angers
Angers, France
  Connect »

Principal Investigator

Clinique du Millenaire Service de Cardiologie Interventionelle
Montpellier, France
  Connect »

Principal Investigator

Hopital Bichat
Paris, France
  Connect »

Principal Investigator

Clinique Saint-Hilaire
Rouen, France
  Connect »

Principal Investigator

Clinique Pasteur / GCVI
Toulouse, France
  Connect »

Principal Investigator

Kerckhoff-Klinik
Bad Nauheim, Germany
  Connect »

Principal Investigator

Segeberger Kliniken
Bad Segeberg, Germany
  Connect »

Principal Investigator

Gesundheit Nord gGmbH
Bremen, Germany
  Connect »

Principal Investigator

St. Johannes - Hospital
Dortmund, Germany
  Connect »

Principal Investigator

Asklepios St. Georg Abteilung fuer Kardiologie
Hamburg, Germany
  Connect »

Principal Investigator

MediClin Herzzentrum Lahr/Baden
Lahr, Germany
  Connect »

Principal Investigator

Herzzentrum Leipzig
Leipzig, Germany
  Connect »

Principal Investigator

Klinikum Oldenburg A R
Oldenburg, Germany
  Connect »

Principal Investigator

Uniklinikum Regensburg, Med II
Regensburg, Germany
  Connect »

Principal Investigator

Universitaetsklinikum Tuebingen Medizinische Klinik, Abteilung III
Tuebingen, Germany
  Connect »

Principal Investigator

Academic Medical Center
Amsterdam, Netherlands
  Connect »

Principal Investigator

Erasmus Medical Center
Rotterdam, Netherlands
  Connect »

Principal Investigator

Hospital Universitario Central de Asturias
Oviedo, Spain
  Connect »

Principal Investigator

Hospital General Universitario de Alicante
Alicante, Spain
  Connect »

Principal Investigator

Complejo Asistencial de Granada
Grenada, Spain
  Connect »

Principal Investigator

Hospital Universitario Ram n y Cajal
Madrid, Spain
  Connect »

Principal Investigator

Hospital Clinico San Carlos
Madrid, Spain
  Connect »

Principal Investigator

Hospital Universitario La Paz
Madrid, Spain
  Connect »

Principal Investigator

Hospital Virgen de la Arrixaca
Murcia, Spain
  Connect »

Principal Investigator

Hospital Universitario Alvaro Cunqueiro
Vigo, Spain
  Connect »

Principal Investigator

BSUH, Cardiac Research Unit
Brighton, United Kingdom
  Connect »

Principal Investigator

Royal Edinburgh Infirmary
Edinburgh, United Kingdom
  Connect »

Principal Investigator

Guys St Thomas Hospital
London, United Kingdom
  Connect »

Principal Investigator

Oxford University Hospitals, John Radcliffe Hospital
Oxford, United Kingdom
  Connect »

Principal Investigator

Northern General Hospital
Sheffield, United Kingdom
  Connect »

Principal Investigator

University Hospital of Wales, Heath Park
Cardiff, United Kingdom
  Connect »

Principal Investigator

University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
  Connect »

Principal Investigator

Derriford Hospital
Plymouth, United Kingdom
  Connect »

Principal Investigator

Memorial Healthcare Systems
Hollywood, FL United States
  Connect »

Principal Investigator

Southern Oregon Cardiology
Medford, OR United States
  Connect »

Principal Investigator

Black Hills Cardiovascular Research
Rapid City, SD United States
  Connect »

Principal Investigator

Wilhelminenspital
Wien, Austria
  Connect »

Principal Investigator

ASZ Aalst - Aalst campus
Aalst, Belgium
  Connect »

Principal Investigator

University of Alberta Hospital
Edmonton, AB Canada
  Connect »

Principal Investigator

Kingston Health Sciences Centre
Kingston, ON Canada
  Connect »

Principal Investigator

Sunnybrook Health Sciences Centre
Toronto, ON Canada
  Connect »

Principal Investigator

Institut Mutualiste Montsouris
Paris, France
  Connect »

Principal Investigator

CHU de Bordeaux Hopital du Haut Leveque
Pessac, France
  Connect »

Principal Investigator

Herz und Gefaess Klinik
Bad Neustadt An Der Saale, Germany
  Connect »

Principal Investigator

IRCCS-ASMN Reggio Emilia
Reggio Emilia, Italy
  Connect »

Principal Investigator

UOC Emodinamica III
Siena, Italy
  Connect »

Principal Investigator

Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
  Connect »

Principal Investigator

Hopitaux Universitaires de Geneve
Geneve, Switzerland
  Connect »

Principal Investigator

University of Massachusetts Memorial Medical Center
Worcester, MA United States
  Connect »

Principal Investigator

Clinical Investigators LLC
Saint Louis, MO United States
  Connect »

Principal Investigator

East Carolina Heart Institute
Greenville, NC United States
  Connect »

Principal Investigator

Promedica Toledo Hospital
Toledo, OH United States
  Connect »

Principal Investigator

St. Luke's University Health Network
Bethlehem, PA United States
  Connect »

Principal Investigator

Legacy Heart Center
Plano, TX United States
  Connect »

Principal Investigator

Providence Sacred Heart Medical Research Center
Spokane, WA United States
  Connect »

Principal Investigator

Newmarket Cardiac Surgery Research Incorporated
Newmarket, ON Canada
  Connect »

Principal Investigator

Institut Coeur Poumon - CHRU de Lille
Lille, France
  Connect »

Principal Investigator

CHU Arnaud de Villeneuve
Montpellier, France
  Connect »

Principal Investigator

AOU Policlinico Vittorio Emanuele
Catania, Italy
  Connect »

Principal Investigator

Fondazione Toscana Gabriele Monasterio
Massa, Italy
  Connect »

Principal Investigator

Bern University Hospital
Bern, Switzerland
  Connect »

Principal Investigator

Cedar-Sinai Heart Institute
Los Angeles, CA United States
  Connect »

Principal Investigator

UCLA Cardiovascular Center
Los Angeles, CA United States
  Connect »

Principal Investigator

Santa Barbara Cottage Hospital
Santa Barbara, CA United States
  Connect »

Principal Investigator

Rush University Medical Center
Chicago, IL United States
  Connect »

Principal Investigator

Maine Medical Center
Scarborough, ME United States
  Connect »

Principal Investigator

Stony Brook University Medical Center
Stony Brook, NY United States
  Connect »

Principal Investigator

Virginia Mason Medical Center
Seattle, WA United States
  Connect »

Principal Investigator

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
Vienna, Austria
  Connect »

Principal Investigator

IRCCS Policlinico San Donato
San Donato Milanese, Italy
  Connect »

Principal Investigator

HagaZiekenhuis
Den Haag, Netherlands
  Connect »

Principal Investigator

Valdecilla Hospital
Santander, Spain
  Connect »

Principal Investigator

Hospital Clinico de Valencia
Valencia, Spain
  Connect »

Principal Investigator

Geisinger Wyoming Valley Medical Center
Wilkes-Barre, PA United States
  Connect »

Principal Investigator

Aurora St. Luke's Medical Center
Milwaukee, WI United States
  Connect »

Principal Investigator

Clinic Wels-Grieskirchen GmbH
Grieskirchen, Austria
  Connect »

Principal Investigator

CHU de Rouen
Rouen, France
  Connect »

Principal Investigator

Klinikum Fulda gAG
Fulda, Germany
  Connect »

Principal Investigator

Universitatsklinikum Ulm
Ulm, Germany
  Connect »

Principal Investigator

Helios Herzzentrum Wuppertal
Wuppertal, Germany
  Connect »

Principal Investigator

Policlinico Sant'Orsola-Malpighi
Bologna, Italy
  Connect »

Principal Investigator

Magna Graecia University
Catanzaro, Italy
  Connect »

Principal Investigator

Centro Cardiologico Monzino IRCCS
Milano, Italy
  Connect »

Principal Investigator

Hospital Clinico Universitario de Valladolid
Valladolid, Spain
  Connect »

Principal Investigator

Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
  Connect »

Principal Investigator

UF Health Jacksonville
Jacksonville, FL United States
  Connect »

Principal Investigator

ASST Spedali Civili di Brescia-UO Cardiologia
Brescia, Italy
  Connect »

Principal Investigator

Centro Cuore Morgagni
Pedara, Italy
  Connect »

See Central Contact

Nagoya Heart Center
Toyohashi, Japan
  Connect »

Principal Investigator

Hospital Universitari Germans Trias I Pujol
Badalona, Spain
  Connect »

Principal Investigator

Loma Linda University Medical Center
Loma Linda, CA United States
  Connect »

Principal Investigator

St. Francis Hospital
East Hills, NY United States
  Connect »

Principal Investigator

University Health Network
Toronto, ON Canada
  Connect »

Principal Investigator

Montreal Heart Institute
Montréal, QC Canada
  Connect »

Principal Investigator

Universit Laval
Québec, Canada
  Connect »

Principal Investigator

Hopital Henri Mondor
Créteil, France
  Connect »

Principal Investigator

Universit tsklinikum D sseldorf
Düsseldorf, Germany
  Connect »

Principal Investigator

Elisabeth Krankenhaus Essen Klinik fur Kardiologie und Angiologie
Essen, Germany
  Connect »

Principal Investigator

Universitatsklinikum Halle (Saale)
Halle, Germany
  Connect »

Principal Investigator

Deutsches Herzzentrum Munchen
München, Germany
  Connect »

Principal Investigator

Universitatsklinikum Wurzburg
Würzburg, Germany
  Connect »

Principal Investigator

ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy
  Connect »

Principal Investigator

Azienda Ospedaliera Integrata di Verona
Verona, Italy
  Connect »