Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)
This is a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology.
The PREVAIL study was amended to initiate a prospective, non-randomized continued access study titled "Continued Access to PREVAIL (CAP2)" to collect additional information on the safety and efficacy of the WATCHMAN LAA closure technology. The study is estimated to enroll an initial cohort of 300 subjects with a maximum of 1500 subjects, at 60 investigational sites in the U.S.
|Atrial Fibrillation Stroke||Device: WATCHMAN Device Drug: Warfarin||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy|
- Primary Endpoints [ Time Frame: 18 month rates ]7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention; Comparison of the composite of stroke, systemic embolism and cardiovascular/unexplained death; Comparison of ischemic stroke and systemic embolism occurring greater than 7 days post randomization.
- Predefined Additional Analyses [ Time Frame: 18 month rates and acute procedure rates ]Device and procedure related events; Mortality; New versus experienced operators; Sensitivity analyses for post procedure population, per protocol #1 population and per protocol #2 population
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||August 2017|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Subjects assigned to receive the WATCHMAN device.
Device: WATCHMAN Device
WATCHMAN Left Atrial Appendage Closure Technology
Active Comparator: Warfarin
Subjects assigned to warfarin therapy.
Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
Other Name: Coumadin
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182441
Show 41 Study Locations
|Principal Investigator:||David R. Holmes, M.D.||Mayo Clinic|
|Principal Investigator:||Vivek Y. Reddy, M.D.||Icahn School of Medicine at Mount Sinai|