WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation (PROTECT AF)
Overview
- Phase
- Phase 2
- Intervention
- WATCHMAN Left Atrial Appendage Closure Technology
- Conditions
- Atrial Fibrillation
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 800
- Locations
- 62
- Primary Endpoint
- Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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%
Arms & Interventions
WATCHMAN
Implant of WATCHMAN Left Atrial Appendage Closure Technology
Intervention: WATCHMAN Left Atrial Appendage Closure Technology
Warfarin control
Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin
Intervention: Warfarin
Roll-in
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.
Intervention: WATCHMAN Left Atrial Appendage Closure Technology
Outcomes
Primary Outcomes
Composite of Stroke, Systemic Embolism and Cardiovascular or Unexplained Death
Time Frame: 5 years
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)
The Occurrence of Life-threatening Events, Including Device Embolization or Serious Bleeding Events
Time Frame: 5 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.
Secondary Outcomes
- Procedure Success(Initial implant procedure)