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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02943785

Public ClinicalTrials.gov record NCT02943785. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 2, 2026, 2:44 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02943785
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
1,426 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 21, 2017 (Actual)
Primary completion
Feb 28, 2021 (Actual)
Completion
Feb 28, 2021 (Actual)
Last update posted
Mar 24, 2022

2017 – 2021

United States locations

U.S. sites
66
U.S. states
32
U.S. cities
63
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
University of Arizona Sarver Heart Center Tucson Arizona 85724 —
Arkansas Site Management Services Little Rock Arkansas 72211 —
Loma Linda University Medical Center Loma Linda California 92354 —
Cedar-Sinai Heart Institute Los Angeles California 90048 —
UCLA Cardiovascular Center Los Angeles California 90095 —
University of California - San Francisco San Francisco California 94143 —
Santa Barbara Cottage Hospital Santa Barbara California 93105-4365 —
Medstar Washington Hospital Center Washington D.C. District of Columbia 20010 —
Medical Facility Associates Washington D.C. District of Columbia 20037 —
Cardiology Associate Research Daytona Beach Florida 32117 —
International Research Partners, LLC. Doral Florida 33166 —
Memorial Healthcare Systems Hollywood Florida 33021 —
UF Health Jacksonville Jacksonville Florida 32209 —
Watson Clinic Center for Research Lakeland Florida 33805 —
Tallahassee Research Institute, Inc. Tallahassee Florida 32308 —
Rush University Medical Center Chicago Illinois 60612 —
Carle Foundation Hospital Urbana Illinois 61801 —
St. Vincent Heart Center Indianapolis Indiana 77030 —
University of Iowa Hospitals and Clinics Iowa City Iowa 52242 —
Maine Medical Center Scarborough Maine 04074-7133 —
Washington Adventist Hospital Takoma Park Maryland 20912 —
Baystate Health Springfield Massachusetts 01199 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01655 —
Sparrow Clinical Research Institute Lansing Michigan 48912 —
MidMichigan Medical Center Midland Midland Michigan 48670 —
Michigan Heart, St. Joseph Mercy Health System Ypsilanti Michigan 48197 —
Essentia Health Duluth Minnesota 55805 —
Mayo Clinic Rochester Rochester Minnesota 55905 —
HealthEast Medical Research Institute Saint Paul Minnesota 55104 —
Jackson Heart Clinic Jackson Mississippi 39216 —
Clinical Investigators LLC St Louis Missouri 63119 —
Renown Regional Medical Center Reno Nevada 89502 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
The Valley Hospital Paramus New Jersey 07652 —
New Mexico Heart Institute Albuquerque New Mexico 87102 —
NY Presbyterian - Brooklyn Methodist Hospital Brooklyn New York 11215 —
St. Francis Hospital East Hills New York 11548 —
St. Joseph's Physicians East Syracuse New York 13057 —
Rochester General Hospital Geneva New York 14456 —
Northshore Community Hospital Manhasset New York 11030 —
Mt. Sinai Hospital New York New York 10029 —
Stony Brook University Medical Center Stony Brook New York 11794-8167 —
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health Greensboro North Carolina 27401 —
East Carolina Heart Institute Greenville North Carolina 27834 —
Promedica Toledo Hospital Toledo Ohio 43615 —
Oklahoma Heart Hospital Research Foundation Oklahoma City Oklahoma 73120 —
Southern Oregon Cardiology Medford Oregon 97504 —
Providence Heart and Vascular Institute Portland Oregon 97225 —
St. Luke's University Health Network Bethlehem Pennsylvania 18015 —
Doylestown Health Cardiothoracic Surgery Doylestown Pennsylvania 18901 —
Penn State Health, Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Geisinger Wyoming Valley Medical Center Wilkes-Barre Pennsylvania 18711 —
Pinnacle Health Wormleysburg Pennsylvania 17043 —
WellSpan York Hospital York Pennsylvania 17403 —
Black Hills Cardiovascular Research Rapid City South Dakota 57701 —
SCRI - Centennial Medical Center Nashville Tennessee 37203 —
Seton Heart Institute Austin Texas 78745 —
Houston Methodist Research Institute Houston Texas 77030 —
University of Texas Health Science Center Houston Houston Texas 77030 —
Legacy Heart Center Plano Texas 75024 —
Inova Heart and Vascular Institute Falls Church Virginia 22042 —
Virginia Mason Medical Center Seattle Washington 98101 —
Providence Sacred Heart Medical Research Center Spokane Washington 99208 —
CAMC Memorial Hospital Charleston West Virginia 25404 —
Aurora St. Luke's Medical Center Milwaukee Wisconsin 53215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 164 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02943785, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 24, 2022 · Synced Nov 2, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02943785 live on ClinicalTrials.gov.

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