WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
Completed
Phase 2/3 ResultsSummary of Purpose
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.
Read More →Trial Milestones
The following dates are available for this trial. Trial information last updated on 29 April 2015.
1 Feb 2005 | 10 Aug 2005 | 1 Aug 2013 | 1 May 2014 | 1 Apr 2015 | 3 Oct 2014 |
Start Date | First Received | 1st Completion | Completion | Verification | Results |
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Trial Design
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Contacts
-
Andrea Stone, BS Phone: 763.746.5005 Email: astone@atritech.net Linn L Laak, BS Phone: 763.746.5026 Email: llaak@atritech.net
astone@atritech.net
View Trial Locations
Recruitment
- Enrollment: 800
- Gender: Both
- Minimum Age: 18 Years
- Accepts Healthy Volunteers: No
- 62 locations, 3 countries
Principal Investigator
- David Holmes, MD
Mayo Clinic