NCT00129545
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
PHASE2
PHASE3
COMPLETED
NCT00129545
INTERVENTIONAL
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
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.
Inclusion Criteria:
* Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)
* Eligible for long term warfarin
* CHADS score \>= 1 \[congestive heart failure (CHF), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (TIA)\]
Exclusion Criteria:
* Contraindicated for warfarin
* Contraindicated for aspirin or clopidogrel (Plavix)
* Congestive heart failure (CHF) Class 4
* Implanted mechanical valve
* Atrial septal or Patent Foramen Ovale (PFO) device
* Platelets \< 100,000 or hemoglobin \< 10
* Left ventricular ejection fraction (LVEF) \< 30%
Atrial Fibrillation
Stroke
- PREVENTION
-
- Type: DEVICE
- Name: WATCHMAN Left Atrial Appendage Closure Technology
- Description: Implant of WATCHMAN Left Atrial Appendage Closure Technology
- Arm Group Labels: Roll-in, WATCHMAN
-
- Type: DRUG
- Name: Warfarin
- Description: Subjects receive warfarin
- Arm Group Labels: Warfarin control
- Boston Scientific Corporation