AMPLATZER AMULET Left Atrial Appendage Occluder Randomized Controlled Trial

Heart & Vascular - Structural Heart Trials, Heart & Vascular
Sameer Gafoor, MD
St. Jude Medical
Jeremy Gillis

Basic eligibility requirements include:

  • Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation 
  • No rheumatic mitral valvular heart disease
  • At high risk of stroke or systemic embolism defined as CHADS2 score >2 or CHADS2-VASC score of >3
  • Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
  • Deemed by investigator to be suitable for short term warfarin but unable to take long term oral anticoagulation
  • Deemed suitable for LAA closure by multidisciplinary team

Basic exclusions include:

  • Requires long-term anticoagulation therapy for a condition other than AF
  • Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
  • Indicated for chronic P2Y12 platelet therapy inhibitor
  • Has undergone ASD or PFO repair or has ASD or PFO closure device
  • Implanted with mechanical valve prosthesis
  • Has contraindications to percutaneous catheterization procedure or cannot accomodate TEE probe
  • Stroke or TIA within 90 days prior to randomization or intervention or surgery planned within 60 days after implant procedure
  • MI within 90 days of randomization
  • NYHA Class IV Congestive Heart Failure
  • Symptomatic carotid artery disease
  • Resting Heart rate > 110bpm
Jeremy Gillis, Research Coordinator II