ENVISAGE TAVI-AF

Condition: Atrial fibrillation

Eligibility

Key Inclusion Criteria

  • Successful TAVI via transvascular access routes such as femoral and subclavian arteries
  • Indication for chronic oral anticoagulation (blood thinning medication taken by mouth)
  • At least 18 years old

Key Exclusion Criteria

  • Conditions with a high risk of bleeding
  • Other known bleeding diathesis (susceptibility to bleed)
  • Conditions that make it difficult for the participant to swallow the study medication

Full Study Name

Edoxaban Versus Standard of Care and their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation—in Atrial Fibrillation (IRB no. 49605)

Summary

The purpose of this study is to examine the safety and effectiveness of an anticoagulant drug called edoxaban versus other anticoagulants (blood thinning medication) in patients who have undergone transcatheter aortic valve implantation (TAVI) and who suffer from atrial fibrillation (irregular heart rate). 

There are two main types of blood thinners: anticoagulants and antiplatelet drugs. Anticoagulants include edoxaban or vitamin-K antagonists (VKA) such as warfarin. Antiplatelet drugs include aspirin and P2Y12 inhibitors. Researchers will compare edoxaban to the standard treatment of a VKA to learn which is more effective in this patient population. Participants will be randomly assigned to one of two study groups. The first group will receive edoxaban, and the second group will receive routine VKA. 

Edoxaban is approved by the U.S. Food and Drug Administration (FDA) for use in certain patients with atrial fibrillation, but it is not approved for patients with atrial fibrillation who undergo TAVI.  

Principal Investigator

Raj Makkar, MD

Contact