NCT01182441

Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation (AF) Versus Long Term Warfarin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	WATCHMAN Device	WATCHMAN Left Atrial Appendage Closure Technology
DRUG	Warfarin	Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0

Timeline

• Start date: 2010-11-01
• Primary completion: 2013-01-01
• Completion: 2017-11-01
• First posted: 2010-08-16
• Last updated: 2018-07-26
• Results posted: 2018-07-26

Locations

41 sites across 1 country: United States