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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-003720
    NCT ID: NCT02943785
    Sponsor Protocol Number: DU176B-C-U4001

About this 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vuyisile Nkomo, M.D., M.P.H.

Contact us for the latest status

Contact information:

Vuyisile Nkomo M.D., M.P.H.

(507)266-3626

nkomo.vuyisile@mayo.edu

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CLS-20359616

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