Title
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)
Phase
Phase 2/Phase 3Lead Sponsor
Boston Scientific CorporationStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Atrial Fibrillation StrokeIntervention/Treatment
warfarin ...Study Participants
800This 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.
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.
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Subjects receive warfarin
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Implant of WATCHMAN Left Atrial Appendage Closure Technology. Up to 3 non-randomized subjects per site, these subjects were not included in the primary analysis.
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%
| Event Type | Organ System | Event Term | Roll-in | WATCHMAN | WARFARIN |
|---|
A Bayesian model allowed for sequential evaluation of the primary endpoints, event rates reported per 100 patient-years (calculated as 100*N events/Total patient-years)
Serious bleeding events evaluated by the Clinical Events Committee included pericardial effusion requiring drainage, cranial bleeding events due to any source, gastrointestinal bleeds requiring transfusion, and any bleeding related to the device or procedure that necessitates an operation.
Implant procedure success is defined as the delivery and release of a WATCHMAN Device into the LAA.
