Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy
Completed · Phase 3
Conditions studied: Atrial Fibrillation, Stroke
In brief
This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.
Key facts
- Study ID
- NCT01182441
- Run by
- Boston Scientific Corporation
- People needed
- 407
- Starts
- 2010-11-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2018-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mercy Gilbert Medical Center — Gilbert, Arizona, United States
- Arizona Heart Rhythm Research Center — Scottsdale, Arizona, United States
- Foundation for Cardiovascular Medicine — La Jolla, California, United States
- Scripps Green — La Jolla, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Orange County Heart — Orange, California, United States
- St. John's Hospital / Pacific Heart — Santa Monica, California, United States
- Zasa Clinical Research — Atlantis, Florida, United States
- Baptist Hospital of Miami — Miami, Florida, United States
- Florida Hospital — Orlando, Florida, United States
- Emory University — Atlanta, Georgia, United States
- North Shore University — Evanston, Illinois, United States
- Iowa Heart Center — Des Moines, Iowa, United States
- Central Baptist Hospital — Lexington, Kentucky, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- William Beaumont — Royal Oak, Michigan, United States
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Cardiology Associates of N. Mississippi — Tupelo, Mississippi, United States
- St. Luke's Hospital — Kansas City, Missouri, United States
- St. John's Mercy — St Louis, Missouri, United States
- Bryan LGH — Lincoln, Nebraska, United States
- Englewood Hospital and Medical Center — Englewood, New Jersey, United States
Full record on ClinicalTrials.gov
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