Last updated on June 2019

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

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Southern Oregon Cardiology

Medford, OR United States
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Mayo Clinic Rochester

Rochester, MN United States
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Seton Heart Institute

Austin, TX United States
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New Mexico Heart Institute

Albuquerque, NM United States
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UCLA Cardiovascular Center

Los Angeles, CA United States
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Washington Adventist Hospital

Takoma Park, MD United States
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Essentia Health

Duluth, MN United States
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East Carolina Heart Institute

Greenville, NC United States
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Carle Foundation Hospital

Urbana, IL United States
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CAMC Memorial Hospital

Charleston, WV United States
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Jackson Heart Clinic

Jackson, MS United States
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The Valley Hospital

Paramus, NJ United States
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Hospital Erasme

Brussels, Belgium
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Legacy Heart Center

Plano, TX United States
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Arkansas Site Management Services

Little Rock, AR United States
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Cardiology Associate Research

Daytona Beach, FL United States
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St. Vincent Heart Center

Indianapolis, IN United States
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Medical Facility Associates

Washington, WA United States
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Santa Barbara Cottage Hospital

Santa Barbara, CA United States
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Promedica Toledo Hospital

Toledo, OH United States
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Segeberger Kliniken

Bad Segeberg, Germany
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Derriford Hospital

Plymouth, United Kingdom
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Maine Medical Center

Scarborough, ME United States
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UF Health Jacksonville

Jacksonville, FL United States
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Clinical Investigators LLC

Saint Louis, MO United States
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Herz und Gefaess Klinik

Bad Neustadt An Der Saale, Germany
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Cedar-Sinai Heart Institute

Los Angeles, CA United States
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Memorial Healthcare Systems

Hollywood, FL United States
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St. Francis Hospital

East Hills, NY United States
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St. Joseph's Physicians

East Syracuse, NY United States
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Northshore Community Hospital

Manhasset, NY United States
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Mt. Sinai Hospital

New York, NY United States
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Pinnacle Health

Wormleysburg, PA United States
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WellSpan York Hospital

York, PA United States
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Kerckhoff-Klinik

Bad Nauheim, Germany
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IRCCS Policlinico San Donato

San Donato Milanese, Italy
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Inova Heart and Vascular Institute

Falls Church, VA United States
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CHU de Liege

Liège, Belgium
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CHU de Liege

Liège, Belgium
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Erasmus Medical Center

Rotterdam, Netherlands
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Royal Edinburgh Infirmary

Edinburgh, United Kingdom
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Northern General Hospital

Sheffield, United Kingdom
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HagaZiekenhuis

Den Haag, Netherlands
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Recruitment Status: Open


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