GALILEO

STUDY IDENTIFIER:

GALILEO

CONDITION:

Post TAVR patients

CONTACT INFO:

Stephanie Ebnet   |   Stephanie.Ebnet@allina.com   |   612-863-6286

DESCRIPTION:

To assess whether an investigational rivaroxaban-based anticoagulation strategy, following TAVR, compared to an antiplatelet-based strategy is superior in reducing death or first thromboembolic events (DTE).

CRITERIA LIST/ QUALIFICATIONS:

  • Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native or valve-in-valve)
    • By iliofemoral or subclavian access with any approved/marketed device.
  • Exclusion Criteria:
    • Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment.
    • Any other indication for continued treatment with any oral anticoagulant (OAC)
    • Clinically significant bleeding.
    • Stroke within the last 3 months.

INVESTIGATORS:

Paul Sorajja, MD

SPONSORS:

Bayer

STATUS:

Open/Enrolling