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

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.

I'M INTERESTED

This research study is led by Dr. Gregory Giugliano.

Contact: Annette Scarnici, RN, CCRC, 413-794-9076

Participation details:

March 21, 2017
BH19-037
Heart
Baystate Medical Center, 759 Chestnut St, Springfield, MA

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

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
Recruiting
Interventional (Clinical Trial), Randomized
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