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.
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol 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.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|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|