NCT00129545

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation

WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, randomized study, stratified by center, comparing the WATCHMAN device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. This study was amended to allow for a non-randomized arm and increased enrollment.

Detailed description

The WATCHMAN device is designed to be permanently implanted distal to the ostium of the left atrial appendage (LAA) to trap potential emboli before they exit the LAA.

Conditions

• Atrial Fibrillation
• Stroke

Interventions

Type	Name	Description
DEVICE	WATCHMAN Left Atrial Appendage Closure Technology	Implant of WATCHMAN Left Atrial Appendage Closure Technology
DRUG	Warfarin	Subjects receive warfarin

Timeline

• Start date: 2005-02-01
• Primary completion: 2013-08-01
• Completion: 2014-05-01
• First posted: 2005-08-12
• Last updated: 2015-05-15
• Results posted: 2015-05-15

Locations

62 sites across 3 countries: United States, Czechia, Germany