Left Atrial Appendage Closure for Atrial Fibrillation – PREVAIL

Left Atrial Appendage Closure for Atrial Fibrillation – PREVAIL

Type of Study
Heart & Vascular - Structural Heart Trials
Location
First Hill Campus
Short Description

Multi-center, randomized study comparing the WATCHMAN Left Atrial Appendage System for Embolic Protection to long-term warfarin therapy, in AF patients eligible for warfarin therapy.

Status
Open
Principal Investigator
Mark Reisman, MD
Eligibility Notes

Key Inclusion Criteria:

  • Paroxysmal, persistent, or permanent non-valvular atrial fibrillation
  • Eligible for long-term warfarin therapy

Key Exclusion Criteria:

  • Class IV CHF
  • Recent MI (within 3 months)
  • ASD, atrial-septal repair or closure device or high risk PFO
  • Single or transient occurrence of AF
  • Cardioversion or ablation planned within 30 days of procedure
  • Implanted mechanical valve prosthesis, obliterated LAA, heart transplant
  • Symptomatic carotid disease
  • Prior embolic stroke or TIA within last 30 days
  • Need for long-term warfarin therapy for reasons other than AF
  • Thrombocytopenia (<100,000 platelets/mm3)
  • Intracardiac thrombus or dense spontaneous echo contrast by TEE within 2 days of implant
  • Significant mitral valve stenosis
  • Complex aortic arch atheroma with mobile plaque
  • Maximum LAA ostium width no greater than 32mm and no less than 17mm and maximum length is no less than maximum width

Follow-up:

  • 45-day, 6-month, 1-year post-procedure TEE
  • 12-, 24-month neurology exam
  • Every 6 months -- phone call follow-up starting at Month 18 through year 5
  • Yearly office follow-up starting at Month 12 through Year 5
Phone
(206) 215-1500
Alternate Phone
(206) 560-0889