Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy "PREVAIL"

Active, not recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Warfarin (Coumadin┬«)Drug
    Intervention Desc: Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
    ARM 1: Kind: Experimental
    Label: Warfarin
    Description: Subjects assigned to warfarin therapy.
  • WATCHMAN Device Device
    Intervention Desc: WATCHMAN Left Atrial Appendage Closure Technology
    ARM 1: Kind: Experimental
    Label: WATCHMAN
    Description: Subjects assigned to receive the WATCHMAN device.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Primary Efficacy Endpoint 6-Months Yes
Primary Primary Endpoints 18 month rates Yes
Secondary Predefined Additional Analyses 18 month rates and acute procedure rates Yes

Sponsors