Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy (PREVAIL)
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|ClinicalTrials.gov Identifier: NCT01182441|
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Stroke||Device: WATCHMAN Device Drug: Warfarin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy|
|Actual Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||November 2017|
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
- Primary Safety Endpoint (Device Group Only) [ Time Frame: 7-Day ]7-Day procedure rate of death, ischemic stroke, systemic embolism and complications requiring major cardiovascular or endovascular intervention.
- Composite of Stroke, Systemic Embolism, and Death (Cardiovascular and Unknown) [ Time Frame: 18 month rate ]The endpoint was analyzed using a Bayesian piecewise exponential model with the historical priors based on data from the previous pivotal study PROTECT AF. This was a non-inferiority design with comparison of rate ratio of 18-month event rates of the Device and Control groups. The 18-month rate represents the probability of an event occurring within 18 months, and the 18-month rate ratio is a mean of the rate ratios. The primary endpoint was based on a calculation of the probability of events at 18 months but the statistical piecewise hazards model does not require the observation of any subjects out to 18-months.
- Composite of Ischemic Stroke or Systemic Embolism [ Time Frame: Day 8 to 18-months ]Composite of ischemic stroke or systemic embolism excluding events that occurred in the first 7 days following randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182441
|Principal Investigator:||David R. Holmes, M.D.||Mayo Clinic|
|Principal Investigator:||Vivek Y. Reddy, M.D.||Icahn School of Medicine at Mount Sinai|